'Global Leaders in Anaesthesia'
Questions and Answers about Naropin
1. What are the physico-chemical properties of Naropin?
Please see the content of the Naropin Product Monograph (1) where the following information can be obtained
Naropin has:
· a molecular weight of 274 as base; 329 as the hydrochloride monohydrate
· a pKa of 8.1
· a distribution ratio (D)* of 141 ( a figure on lipid solubility)
*D = C org /C aq for the system n-octanol/phosphate buffer at pH 7.4 and 25 C.
In general, Naropin exhibits a high protein binding capacity (90 to 95% in
plasma) and thus has the potential of a long duration of action (1).
Please observe that the lipid solubility differs with temperature and the type of fat.
2. How does the efficacy of Naropin compare with that of Marcain (bupivacaine) for surgical procedures under epidural anaesthesia?
Surgical anaesthesia
Naropin provides effective and well-tolerated anaesthesia for surgery. The anaesthetic effects are dose dependent, which means that the degree of sensory and motor block achieved with the drug is predictable. Furthermore, Naropin may be given at higher doses than bupivacaine to provide reliable and long-lasting anaesthesia, with less risk of systemic toxicity.
Epidural anaesthesia
The efficacy of Naropin as an epidural anaesthetic for surgery has been investigated in a number of clinical studies, most of which involved a double-blind comparison of the efficacies of Naropin and bupivacaine. Individuals undergoing a variety of surgical procedures (orthopaedic, gynaecological and urological surgery, and surgery of the lower abdomen and lower limbs) are included in a number of double-blind studies. Naropin has been given at concentrations of 5.0, 7.5 or 10.0 mg/ml (10 to 25 ml, total doses of 100 - 250 mg), while bupivacaine, 5.0 or 7.5 mg/ml (15 to 25 ml, total doses of 100 - 150 mg), served as the comparator.
Naropin has been found to be an effective and well-tolerated epidural anaesthetic for Caesarean section (see separate GEM entry for Caesarean Section).
Clinicians should consult local prescribing information before use of Naropin.
Surgical procedures under epidural anaesthesia
High doses of Naropin (200 to 250 mg) produce more satisfactory conditions for surgery than those achieved with the maximum recommended dose of bupivacaine (150 mg). The time to onset of sensory block achieved with Naropin do not vary markedly between doses, while the duration of sensory block increase as the dose of anaesthetic increase (1-9).
References :
1. Sandler A, Arlander E, Finucane BT et al. Pharmacokinetics of three doses of epidural ropivacaine during hysterectomy and comparison with bupivacaine. Can J Anaesth 1998;45:843-849.
2. McGlade DP, Kalpokas MV, Mooney PH et al. Comparison of 0.5% ropivacaine and 0.5% bupivacaine in lumbar epidural anaesthesia for lower limb orthopaedic surgery. Anaesth Intensive Care 1997;25:262-266.
3. Finucane BT, Sandler AN, McKenna J et al. A double-blind comparison of ropivacaine 0.5%, 0.75%, 1.0% and bupivacaine 0.5%, injected epidurally, in patients undergoing abdominal hysterectomy. Can J Anaesth 1996;43:442-449.
4. Tuttle AA, Katz JA, Bridenbaugh PO et al. A double-blind comparison of the abdominal wall relaxation produced by epidural 0 75% ropivacaine and 0 75% bupivacaine in gynecologic surgery. Reg Anesth 1995;20:515-520.
5. Morrison LM, Emanuelsson BM, McClure JH et al. Efficacy and kinetics of extradural ropivacaine: comparison with bupivacaine. Br J Anaesth 1994;72:164-169.
6. Cederholm I, Anskär S, Bengtsson M. Sensory, motor, and sympathetic block during epidural analgesia with 0 5% and 0 75% ropivacaine with and without epinephrine. Reg Anesth 1994;19:18-33.
7. Wood MB, Rubin AP. A comparison of epidural 1% Ropivacaine and 0.75% bupivacaine for lower abdominal gynecologic surgery. Anesth Analg 1993;76:1274-1278.
8. Brockway MS, Bannister J, McClure JH et al. Comparison of extradural ropivacaine and bupivacaine. Br J Anaesth 1991;66:31-37.
9. Katz JA, Knarr D, Bridenbaugh PO. A double-blind comparison of 0.5% bupivacaine and 0.75% ropivacaine administered epidurally in humans. Reg Anesth 1990;15:250-252.
3. How does the efficacy of Naropin compare with that of Marcain (bupivacaine) for Caesarean Section under epidural anaesthesia?
Surgical anaesthesia
Naropin provides effective and well-tolerated anaesthesia for surgery. The anaesthetic effects are dose dependent, which means that the degree of sensory and motor block achieved with the drug is predictable. Furthermore, Naropin may be given at higher doses than bupivacaine to provide reliable and long-lasting anaesthesia, with less risk of systemic toxicity.
Epidural anaesthesia
The efficacy of Naropin as an epidural anaesthetic for surgery has been investigated in a number of clinical studies, most of which involved a double-blind comparison of the efficacies of Naropin and bupivacaine. Individuals undergoing a variety of surgical procedures (orthopaedic, gynaecological and urological surgery, and surgery of the lower abdomen and lower limbs - see GEM 1400 re- surgical procedures under epidural anaesthesia) are included in a number of double-blind studies. Naropin has been given at concentrations of 5.0, 7.5 or 10.0 mg/ml (10 to 25 ml, total doses of 100–250 mg), while bupivacaine, 5.0 or 7.5 mg/ml (15 to 25 ml, total doses of 100–150 mg), served as the comparator.
Caesarean Section
Naropin is an effective epidural analgesic for labour pain. It provides reliable pain relief with a lower frequency of motor block compared with bupivacaine (1–7).
Naropin has been found to be an effective and well-tolerated epidural anaesthetic for Caesarean Section.
Clinicians should consult local prescribing information before use of Naropin.
References :
1. Bjornestad E, Smedvig JP, Bjerkreim T et al. Epidural ropivacaine 7.5 mg/ml for elective caesarean section: a double- blind comparison of efficacy and tolerability with bupivacaine 5 mg/ml. Acta Anaesthesiol Scand 1999;43:603-608.
2. Stienstra R. Ropivacaine in obsetrics [obstetrics]. van Zundert A, editor(s). In: Highlights in pain therapy and regional anesthesia. VII: XVII Annual ESRA Congress, Geneva, September 16-19, 1998. Limassol: Hadjigerogiou Printings & Co, 1998:70-75.
3. Crosby E, Sandler A, Finucane B et al. Comparison of epidural anaesthesia with ropivacaine 0.5% and bupivacaine 0.5% for caesarean section. Can J Anaesth 1998;45:1066-1071.
4. Writer WD, Stienstra R, Eddleston JM et al. Neonatal outcome and mode of delivery after epidural analgesia for labour with ropivacaine and bupivacaine: a prospective meta-analysis. Br J Anaesth 1998;81:713-717.
5. Cederholm I. Preliminary risk benefit analysis of ropivacaine in labour and following surgery. Drug Saf 1997;16:391-402.
6. Morton CP, Bloomfield S, Magnusson A et al. Ropivacaine 0.75% for extradural anaesthesia in elective caesarean section: an open clinical and pharmacokinetic study in mother and neonate. Br J Anaesth 1997;79:3-8.
7. Griffin RP, Reynolds F. Extradural anaesthesia for caesarean section: a double-blind comparison of 0.5% ropivacaine with 0.5% bupivacaine. Br J Anaesth 1995;74:512-516.
4. Can Naropin be used for postoperative epidural analgesia?
Epidural Naropin 2.0 mg/ml, infused at a rate of 6 to 14 ml/h, provides reliable postoperative pain relief, with minimal non-progressive motor block and a reduced need for morphine analgesia (1-6).
Clinicians should consult local prescribing information before use of Naropin.
References :
1. Kampe S, Weigand C, Kaufmann J et al. Postoperative analgesia with no motor block by continuous epidural infusion of ropivacaine 0.1% and sufentanil after total hip replacement. Anesth Analg 1999;89:395-398.
2. Jayr C, Beaussier M, Gustafsson U et al. Continuous epidural infusion of ropivacaine for postoperative analgesia after major abdominal surgery: comparative study with iv PCA morphine. Br J Anaesth 1998;81:887-892.
3. Scott DA, Emanuelsson BM, Mooney PH et al. Pharmacokinetics and efficacy of long-term epidural ropivacaine infusion for postoperative analgesia. Anesth Analg 1997;85:1322-1330.
4. Badner NH, Reid D, Sullivan P et al. Continuous epidural infusion of ropivacaine for the prevention of postoperative pain after major orthopaedic surgery: a dose-finding study. Can J Anaesth 1996;43:17-22.
5. Scott DA, Blake D, Buckland M et al. A comparison of epidural ropivacaine infusion alone and in combination with 1, 2, and 4 microg/mL fentanyl for seventy-two hours of postoperative analgesia after major abdominal surgery. Anesthesia and Analgesia 1999;88(4):857-64.
6. Finucane BT, Ganapathy S, Carli F et al. Prolonged epidural infusions of ropivacaine (2 mg/mL) after colonic surgery: The impact of adding fentanyl.. Anesthesia and Analgesia 2001;92(5):1276-85..
5. Use of Naropin for field block / infiltration analgesia/peripheral nerve block
Naropin at concentrations of 1.25 and 2.5 mg/ml infiltrated into the region of the wound before surgery is shown to give excellent postoperative analgesic compared with that of placebo. Patient-controlled interscalene analgesia (PCIA) with Naropin 2 mg/ml provides better pain control, better respiratory function, better hemidiaphragmatic excursion and a lower incidence of side effects, and a higher degree of patient satisfaction after major shoulder surgery than patient- controlled intravenous analgesia (PCIVA) with opioids (1-3).
Clinicians should consult local prescribing information before use of Naropin.
References :
1 . Borgeat A, Perschak H, Bird P et al. Patient-controlled interscalene analgesia with ropivacaine 0.2% versus patient-controlled intravenous analgesia after major shoulder surgery: effects on diaphragmatic and respiratory function. Anesthesiology 2000;92:102-108.
2. Horn EP, Schroeder F, Wilhelm S et al. Wound infiltration and drain lavage with ropivacaine after major shoulder surgery. Anesth Analg 1999;89:1461-1466.
3. Fanelli G, Casati A, Beccaria P et al. A double-blind comparison of ropivacaine, bupivacaine, and mepivacaine during sciatic and femoral nerve blockade. Anesth Analg 1998;87:597-600.
6. Is Naropin less toxic to the CNS than bupivacaine in humans?
Naropin is less toxic to the CNS than bupivacaine in humans.
Two volunteer studies compared the doses of Naropin and bupivacaine given to volunteers via intravenous infusion before the onset of CNS toxicity (1,2). In all cases, the infusion rate for each anaesthetic was 10 mg/min. The results of both studies demonstrated that more volunteers tolerated higher doses of Naropin than bupivacaine before the onset of perioral numbness or twitching.
References :
1. Knudsen K, Beckman M, Blomberg S et al. Central nervous and cardiovascular effects during i.v. infusions of ropivacaine, bupivacaine and placebo in volunteers. Brit J Anaesthesia 1997;78:507-514.
2. Scott DB, Lee A, Fagan D et al. Acute toxicity of ropivacaine compared with that of bupivacaine. Anesth Analg 1989;69:563–569.
7. Is Naropin less cardiotoxic than bupivacaine in humans?
Naropin less cardiotoxic than bupivacaine in humans.
In volunteer studies, electrocardiogram examination showed that, at the end of the infusion period in which 10 mg/min of either drug had been given, bupivacaine significantly increased the QRS width, PR interval and QT interval compared with both placebo and Naropin. This indicates that bupivacaine has a more deleterious effect on heart function, particularly on the conduction of nerve impulses through the muscles of the heart, than Naropin. In addition, echocardiography revealed that cardiac performance was more seriously impaired following bupivacaine infusion than Naropin infusion, due to a reduction in ventricular contractility (1-3).
References :
1. Naropin Product Monograph, September 2003.
2. Knudsen K, Beckman M, Blomberg S et al. Central nervous and cardiovascular effects during i.v. infusions of ropivacaine, bupivacaine and placebo in volunteers. Brit J Anaesthesia 1997;78:507-514.
3. Scott DB, Lee A, Fagan D et al. Acute toxicity of ropivacaine compared with that of bupivacaine. Anesth Analg 1989;69:563-569.
8. Can the Polyamp and Polybag presentations of Naropin be frozen?
Naropin in Polyamp Duofit ampoules and Polybag infusion bags must not be frozen. If accidentally frozen, the affected packs must be discarded.
They should be stored at room temperature, below 30 degrees C (1).
References :
1. Naropin Core Data Sheet, April , 2007
9. Can a presentation of Naropin be re-sterilized once a blister pack has been opened?
Polyamp ampoules and Polybag infusion bags should not be re-sterilized once removed from the blister pack. However, only the outside of the Polyamp ampoule and Polybag is no longer sterile. Naropin within the Polyamp ampoule and Polybag remains sterile until opened (1).
References :
1. Naropin Core Data Sheet, April , 2007
10. Does the pH of Naropin solutions need to be adjusted before use?
Naropin solutions are intended for use straight from the pack and do not require any adjustment before use. Naropin, 2.0 mg/ml, 5.0 mg/ml, 7.5 mg/ml and 10 mg/ml, is prepared as a sterile, isotonic, aqueous solution. Solutions of Naropin are adjusted to a pH of 4.0–6.0. However, it should be noted that Naropin has limited solubility above pH 6.0, and may precipitate out of solution (1).
References :
1. Naropin Core Data Sheet, April , 2007
11. Does Naropin contain preservatives?
Naropin solutions are preservative free. Once Polyamp ampoules and Polybags have been opened, the contents should be used immediately and any unused solution discarded (1).
References :
1. Naropin Core Data Sheet, April , 2007
12. What is the baricity of Naropin?
Baricity is the relationship between the density of the cerebrospinal fluid (CSF) and the density of the injectable.
The density of both the CSF and the injectable decreases with increasing temperature and increases with decreasing temperature, at least down to 4 degrees C, when water has its highest density. So, the baricity for a certain injectable is always the same.
Normally the density of CSF is given at the temperature 37 degrees C (body temperature) with the density 1.0003 g/qcm. The baricity is 1.000.
Naropin solutions (2, 5, 7.5 and 10 mg/ml) have the density of 1.004 g/cm3 at 20 degrees C. Calculated to 37 degrees C the density of those solutions will be 0.9991. The quote between 0.9991 and 1.0003 will then result in the baricity of 0.9988 for the Naropin solutions.
The osmolality for all Naropin solutions is 285 mOsm/kg as they are isotonic to physiological saline solutions (1).
References :
1. Data on file, AstraZeneca.
13. What are the pharmacokinetic properties of Naropin (ropivacaine)?
The pharmacokinetic profile of Naropin (ropivacaine), in adults after intravenous administration and in children aged 1-12 years after regional anaesthesia, is outlined below (1-5).
Adults Children aged 1-12 years
Plasma clearance 440 ml/min 7.5 ml/min kg
Unbound plasma clearance 8 l/min 0.15 l/min kg
Renal clearance 1 ml/min -
Volume of distribution at steady state 47 l 2.4 l/kg
Terminal/elimination half-life 1.8 h 3 h
Unbound fraction 6% 5%
Hepatic extraction ratio 0.4 -
References :
1. Lee A, Fagan D, Lamont M et al. Disposition kinetics of ropivacaine in humans. Anesth Analg 1989;69:736-738.
2. Vinnars E, Emanuelsson B-M, Sandin S. Basic pharmacokinetics of ropivacaine and its stable isotope labelled analogue in volunteers. Astra Report 802-550-LK-0064-01, 1993-10-11.
3. Emanuelsson B-M, Persson J, Alm C et al. Pharmacokinetics of ropivacaine after three intravenous doses [abstract]. Clin Pharmacol Ther 1994;55:123.
4. Halldin MM, Bredberg E, Angelin B et al. Metabolism and excretion of ropivacaine in humans. Drug Metab Dispos 1996;24:962-968.
5. Naropin Core Data Sheet., September 2003.
14. Where is Naropin (ropivacaine) metabolised?
The principal site of Naropin (ropivacaine) metabolism is the liver, and the predominant metabolic pathway is aromatic 3-hydroxylation. Naropin is metabolised extensively in the liver, and only about 1% of each dose is excreted unchanged in the urine (1,2).
References :
1. Halldin MM, Bredberg E, Angelin B et al. Biotransformation and excretion of ropivacaine in humans. Drug Metab Dispos 1996;34:962-968.
2. Halldin M, Osterlof G, Elofssons S. Biotransformation of ropivacaine (LEA103) in man after an intravenous infusion. Astra Report 802-50 AF 73-1, 1986-12-01.
15. What are the metabolites of Naropin (ropivacaine)?
The major metabolite of Naropin (ropivacaine) is 3-hydroxy-ropivacaine. In urine analysis, 3-hydroxy-ropivacaine constitutes approximately 37% of the total Naropin dose administered, whereas pipecoloxylidide (PPX) and 3-hydroxy-PPX comprise about 3% and 2% of the total dose, respectively. Other identified metabolites each form less than 1% of the total dose (1,2). 2,6-xylidine and 4-OH-xylidine are not metabolic products of Naropin (3).
References :
1. Halldin MM, Bredberg E, Angelin B et al. Biotransformation and excretion of ropivacaine in humans. Drug Metab Dispos 1996;34:962-968.
2. Halldin M, Osterlof G, Elofssons S. Biotransformation of ropivacaine (LEA103) in man after an intravenous infusion. Astra Report 802-50 AF 73-1, 1986-12-01.
3. Wehler EK, Von Euler Chelpin H, Elofsson S et al. Ropivacaine – further identification of metabolites. Drug Metab Rev 2001;33(Suppl S):207, Abs 411.
16. What are the indications for Naropin in surgical anaesthesia?
Naropin, administered as a lumbar epidural, is indicated for surgical procedures, such as Caesarean section and orthopaedic, lower abdominal and upper abdominal surgery. It is administered by thoracic epidural to establish block for postoperative pain relief. Naropin is also indicated for spinal administration, major nerve block and field block (1).
The full local prescribing information should always be consulted before administering Naropin.
References :
1. Naropin Core Data Sheet, April , 2007
17. Is Naropin approved for use in children?
Naropin is approved for use in adults and children aged 12 years and older for surgical anaesthesia and acute pain management. It is also approved for acute pain management in paediatric patients aged 01–12 years. See question 23 for further details.
The full local prescribing information should always be consulted before administering Naropin.
References :
1. Naropin Core Data Sheet, April , 2007
18. What is the recommended epidural dose of Naropin for effective surgical anaesthesia?
The recommended dose for surgical indications is Naropin 113–200 mg, given as Naropin 7.5 mg/ml (15–25 ml) or 10 mg/ml (15–20 ml) (1).
These doses are those normally necessary for successful block, and should be regarded as guidelines for use in adults. Individual variations in onset and duration occur.
References :
1. Naropin Core Data Sheet, April , 2007
19. What is the effective epidural dose of Naropin for Caesarean Section?
The recommended dose for Caesarean Section is Naropin 113–150 mg, given as Naropin 7.5 mg/ml (15–20 ml) (1).
References :
1. Naropin Core Data Sheet, April , 2007
20. What is the dose range of Naropin for infiltration anaesthesia for minor surgery, and what is the onset time?
The recommended dose for infiltration anaesthesia for minor surgery is Naropin 7.5– 225 mg (1). The time to onset of anaesthesia following infiltration with Naropin is very short (1–15 minutes) (1,2).
References :
1. Naropin Core Data Sheet, April , 2007
2. Stenquist B, Rissler-Maier K, Näsman P et al. Local infiltration with ropivacaine 0.5% and mepivacaine 1.0% in patients operated upon for benign naevi: a double-blind comparison. Astra Report 802-550-LC-0198-01, 1994-06-10.
21. What is the maximum recommended dose of Naropin?
Currently, there is no absolute maximum recommended dose for Naropin. However, the Naropin Core Data Sheet recommends a range of doses for each indication that will provide effective anaesthesia or analgesia in the average patient (1). Such guidelines enable the anaesthetist to select the dose likely to be most appropriate for each patient, aiming at the minimum effective dose. It remains essential that the anaesthetist is aware of the signs of systemic toxicity, and has adequate knowledge and facilities to treat toxic reactions, should they occur.
References :
1. Naropin Core Data Sheet, April , 2007
22. Is Naropin indicated for intravenous regional anaesthesia?
No.
Naropin is not indicated for intravenous regional anaesthesia. Naropin has been given intravenously to volunteers solely to establish its tolerability profile and its pharmacokinetic properties. Long-acting, lipophilic local anaesthetics are not recommended for intravenous regional anaesthesia under any circumstances.
References :
1. Naropin Core Data Sheet, April , 2007
23. What are the indications for Naropin in acute pain management?
In acute pain management in adults, Naropin 2.0 mg/ml is indicated for:
- Lumbar Epidural Administration
o Continuous infusion or intermittent bolus administration e.gg postoperative or labour pain management
- Thoracic Epidural Administration
o Continuous infusion
- Field block (minor nerve block or infiltration)
- Intra-articular injection (Naropin 7.5 mg/ml)
- Continuous peripheral nerve block infusion or intermittent injections, eg postoperative pain management
Naropin is also indicated for acute pain management in paediatric patients aged 0-12 years (for per-and postoperative pain management):
- Single caudal epidural block (Naropin 2.0 mg/ml) in paediatric patients aged 0 to 12 years
- Peripheral nerve block (Naropin 5.0 mg/ml) in paediatric patients aged 1 to 12 years
- Continuous epidural infusion (Naropin 2.0 mg/ml) in paediatric patients aged 0 to 12 years
The full local prescribing information should always be consulted before administering Naropin.
References :
1. Naropin Core Data Sheet, April 2007.
24. After which operations does Naropin provide effective postoperative pain relief?
Naropin provides effective postoperative pain relief following upper abdominal surgery with the incision predominantly above the umbilicus (ventricular resection and fundoplication), major abdominal surgery with the incision predominantly below the umbilicus (major colonic surgery, rectal amputation, bladder surgery and hysterectomy), and orthopaedic surgery of the upper and lower limb (shoulder and hand surgery, total hip arthroplasty, total knee arthroplasty, cruciate ligament reconstruction and internal fixation of femur fracture) (1-6).
References :
1. Fried M, Ström S, Morton C et al. Continuous epidural infusion of ropivacaine for the prevention of postoperative pain after major lower abdominal surgery: a dose finding study [abstract]. Int Monitor Reg Anaesth 1994;36.
2. Badner NH, Reid D, Sullivan P et al. Continuous epidural infusion of ropivacaine for the prevention of postoperative pain after major orthopaedic surgery: a dose finding study [abstract]. Anesthesiology 1994;81:3A.
3. Wood MB, Rubin AP. A comparison of epidural 1% Ropivacaine and 0.75% bupivacaine for lower abdominal gynecologic surgery. Anesth Analg 1993;76:1274-1278.
4. Borgeat A, Kalberer F, Jacob H, Ruetsch YA, Gerber C. Patient-controlled interscalene analgesia with ropivacaine 0.2% versus bupivacaine 0.15% after major open shoulder surgery: the effects on hand motor function. Anesthesia and Analgesia 2001;92(1):218-223..
5. Borgeat A, Perschak H, Bird P, Hodler J, Gerber C. Patient-controlled interscalene analgesia with ropivacaine 0.2% versus patient-controlled intravenous analgesia after major shoulder surgery: effects on diaphragmatic and respiratory function. Anesthesiology 2000;92(1):102-8..
6. Finucane BT, Ganapathy S, Carli F et al. Prolonged epidural infusions of ropivacaine (2 mg/mL) after colonic surgery: The impact of adding fentanyl.. Anesthesia and Analgesia 2001;92(5):1276-85..
25. How fast is the onset of pain relief with epidural Naropin administration during labour?
The onset of pain relief is rapid. In studies in which Naropin was administered by repeat top-up doses, the median time to onset of pain relief was 12–13 min. Similar onset times (15–18 min) were achieved when Naropin was given as a bolus followed by continuous infusion for pain relief during labour (1–3).
References :
1. Stienstra R, Jonker T, Bourdrez P et al. Ropivacaine 0.25% versus bupivacaine 0.25% for continuous epidural analgesia in labour: a double-blind comparison. Obstetric Anesthesia 1995;80:285–289.
2. Douglas MJ, Weeks SB, Gambling DR et al. A double-blind comparison between epidural ropivacaine 0.25% and bupivacaine 0.25% for the relief of pain during childbirth: report of a multicentre study [abstract]. Reg Anesth 1994;19(Suppl 2S):52.
3. Eddleston JM, Holland JJ, Griffin R et al. A double-blind comparison of 0.25% ropivacaine and 0.25% bupivacaine for extradural analgesia in labour. Br J Anaesth. 1996;76:66-71.
26. What is the recommended dose of Naropin in pain relief during labour?
For pain relief by continuous infusion, the recommended dose is Naropin 12–20 mg/h. Alternatively, pain relief can be initiated by giving Naropin as a 20–40 mg bolus, followed by 20–30 mg top-up doses as required, with a minimum interval of 30 minutes (1).
References :
1. Naropin Core Data Sheet, April , 2007
27. What is the recommended concentration and infusion rate for Naropin in pain relief during labour?
The recommended Naropin concentration and infusion rate is 2.0 mg/ml, at 6–10 ml/h (1).
References :
1. Naropin Core Data Sheet, April , 2007
28. Does administration of Naropin complicate delivery?
No.
Compared with bupivacaine, epidural infusion of Naropin during delivery offers significant advantages in terms of reductions in delivery complications and neonatal neurological outcome. A meta-analysis of the results from obstetric studies has shown that Naropin is associated with a significantly greater number of spontaneous deliveries and a significantly improved neonatal NAC score, assessed 24 h after delivery, than bupivacaine (1).
One study also reports that the duration of labour and the time from administration of the main dose to transition to stage II of labour was shorter in patients given Naropin as top-up doses than in those given bupivacaine. Additionally, patients given Naropin required fewer top-up doses and, therefore, received a smaller total dose of drug than those given bupivacaine. It was also noted during this study that Naropin produced a significantly lower maximum degree of motor block than bupivacaine (2).
References :
1. Writer WD, Stienstra R, Eddleston JM et al. Neonatal outcome and mode of delivery after epidural analgesia for labour with ropivacaine and bupivacaine: a prospective meta-analysis. Br J Anaesth 1998;81:713-717.
2. Gatt SP, Crooke DK, Anderson A et al. Pain relief and sensory and motor block in mothers receiving epidural ropivacaine 0.25% and bupivacaine 0.25% for analgesia in labour – a double-blind, parallel, randomised comparison of efficacy. Eur J Anaesthesiol 1996;13:152.
29. What concentrations of Naropin are available?
Four concentrations of Naropin are available: 2.0 mg/ml, 5.0mg/ml, 7.5 mg/ml and 10 mg/ml. All concentrations are presented in polypropylene ampoules (Polyamp), of 10 and 20 ml, for single-dose administration. The 2.0 mg/ml concentration is also presented as a ready-to-use, epidural infusion bag (Polybag), of 100 and 200 ml. Both the Polyamps and Polybags are available in blister packs.
The ampoules are designed to fit Luer lock and Luer fit syringes.
References :
1. Naropin Core Data Sheet, April , 2007
30. What volumes of Naropin are available?
For single-dose administration of Naropin, 10 ml and 20 ml Polyamp polypropylene ampoules are available. For continuous epidural infusions, Naropin is presented as Polybag epidural infusion bags, containing either 100 ml or 200 ml of Naropin.
References :
1. Naropin Core Data Sheet, April , 2007
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