Naropin (Ropivacaine Hydrochloride Monohydrate) - Summary

NAROPIN SUMMARY

Naropin^® Injection contains ropivacaine HCl which is a member of the amino amide class of local anesthetics. Naropin Injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and Water for Injection. Sodium hydroxide and/or hydrochloric acid may be used for pH adjustment. It is administered parenterally.

Naropin is indicated for the production of local or regional anesthesia for surgery and for acute pain management.

Surgical Anesthesia:epidural block for surgery including cesarean section; major nerve block; local infiltration

Acute Pain Management:epidural continuous infusion or intermittent bolus, eg, postoperative or labor; local infiltration

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NEWS HIGHLIGHTS

Published Studies Related to Naropin (Ropivacaine)

The median effective dose of bupivacaine, levobupivacaine, and ropivacaine after intrathecal injection in lower limb surgery. [2009.10]
BACKGROUND: Intrathecal anesthesia is commonly used for lower limb surgery. Bupivacaine, levobupivacaine, and ropivacaine have all been used as intrathecal drugs, but their relative potency in this context has not been fully determined. In this study, we determined the median effective dose (ED(50)) of these three local anesthetics for intrathecal anesthesia in lower limb surgery and hence their relative potencies... CONCLUSION: This study suggests that in intrathecal anesthesia for lower limb surgery, ropivacaine is less potent than levobupivacaine and bupivacaine, whereas the potency is similar between levobupivacaine and bupivacaine.

A comparison of high volume/low concentration and low volume/high concentration ropivacaine in caudal analgesia for pediatric orchiopexy. [2009.10]
BACKGROUND: It is unclear whether the volume or concentration of local anesthetic influences its spread and quality of caudal analgesia when the total drug dose is fixed... CONCLUSIONS: We confirmed (with fluoroscopy) that a caudal block with 1 mL/kg ropivacaine spreads to T11 and to T6 with 1.5 mL/kg. If the total dose is fixed, caudal analgesia with a larger volume of diluted ropivacaine (0.15%) provides better quality and longer duration after discharge than a smaller volume of more concentrated ropivacaine (0.225%) in children undergoing day-case orchiopexy. The spread level of ropivacaine correlated significantly with the first oral acetaminophen time after discharge.

Analgesic effectiveness of ropivacaine 0.2% vs 0.4% via an ultrasound-guided C5-6 root/superior trunk perineural ambulatory catheter. [2009.09]
BACKGROUND: In this prospective, randomized, triple-blinded study, we tested the hypothesis that a 48 h continuous C5-6 root/superior trunk patient-controlled infusion of ropivacaine 0.4% would provide superior analgesia after shoulder surgery compared with the same infusion of ropivacaine 0.2%... CONCLUSIONS: After major shoulder surgery, ropivacaine 0.2% at 2 ml h(-1) with on-demand 5 ml boluses administered via an ultrasound-guided C5-6 root/superior trunk perineural catheter produces similar analgesia, but higher patient satisfaction compared with ropivacaine 0.4%. Trial Registration: ANZCTR: ACTRN12608000591358. URL: www.anzctr.org.au/registry/trial_review.aspx?ID=83028.

Efficacy of subacromial ropivacaine infusion for rotator cuff surgery. A randomized trial. [2009.07]
BACKGROUND: Local anesthetic administered directly to the operative site by slow infusion has become a popular supplementary pain management strategy following rotator cuff surgery, but it is expensive and there is little conclusive evidence that it provides additional benefits. The purpose of this study was to determine the effectiveness and safety of ropivacaine infusion following arthroscopic or mini-incision rotator cuff surgery... CONCLUSIONS: We found minimal evidence to support the use of ropivacaine infusion for improving outcomes following rotator cuff surgery in the setting of preemptive ropivacaine and intraoperative parecoxib.

The analgesic properties of scalp infiltrations with ropivacaine after intracranial tumoral resection. [2009.07]
BACKGROUND: The issue of postoperative pain after neurosurgery is controversial. It has been reported as mild to moderate and its treatment may be inadequate. Infiltration of the surgical site with local anesthetics has provided transient benefit after craniotomy, but its effect on chronic pain has not been evaluated. Accordingly, we designed the present study to test the hypothesis that ropivacaine infiltration of the scalp reduces acute and persistent postoperative pain after intracranial tumor resection... CONCLUSIONS: Because pain is moderate after intracranial tumor resection, there is limited interest in scalp infiltrations with ropivacaine in the acute postoperative period. Nevertheless, these infiltrations may be relevant for the rehabilitation of neurosurgical patients and their quality of life by limiting the development of persistent pain and particularly neuropathic pain.

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Clinical Trials Related to Naropin (Ropivacaine)

Labor Analgesia With Ropivacaine and Clonidine [Completed]
The aim of the present study was to examine, for pain relief during labor, the efficacy of two pharmacological approaches — the 0. 125% ropivacaine alone and the 0. 0625% ropivacaine added to 75 ug clonidine, both by epidural administration. The effect of the drugs on mother and newborn was also determined.

Ropivacaine Versus Bupivacaine for Spinal Anaesthesia in Patients Undergoing Unilateral Lower Limb Surgery [Completed]
The purpose of this study is to compare the efficacy, duration of motor block until return to normal function in the non-operated leg after the start of injection, of ropivacaine 5 mg/ml and bupivacaine 5 mg/ml when used for spinal anaesthesia in patients undergoing unilateral lower limb surgery.

Interscalene Nerve Blocks With Ropivacaine Alone, With Dexamethasone, Plus Systemic Dexamethasone [Recruiting]
This study will test the hypothesis that ropivacaine in combination with either systemic or local steroid provides comparably longer-lasting analgesia tha ropivacaine alone.

Ropivacaine vs Ropivacaine Plus Mepivacaine for Sciatic Block [Recruiting]
In loco regional anesthesia, much more than for general anesthesia, the choice of the product is largely left at the discretion of the practitioner. Two categories of local anesthetics are distinguished according to their pharmacodynamic characteristics: products with a short time of installation and a short duration period, and products with a longer delay of installation of the sensitive and motor block, but with a long-term duration. Indeed, the combined use of two products pharmacodynamically different seems to be of a practical interest.

This study provides a comparison of the onset of action of 30 ml of ropivacaine 0. 75% and 30ml of a mixture of ropivacaïne 0. 75% associated with mepivacaïne 1. 5% for the subgluteal sciatic nerve block. This is a prospective randomized double-blind study where the main criterion of judgment is the time of installation of a sensitive block compatible with surgery in the sciatic territory nerve. Fifteen patients per group were calculated to detect a 50% decrease of the onset of action in the combination group with a power of 90% and alpha to 5%, according to a previous pilot study. The secondary endpoints are the intensity and time of installation of the motor block, the duration of sensitive and motor block, the total dose of morphine administered within 48 hours, as well as its possible side effects.

Pain Relief by Intra-Peritoneal Ropivacaine During Gynecological Laparoscopy [Completed]
In our prospective, randomized, placebo controlled and double-blinded study we will study the efficacy of intraperitoneal ropivacaine nebulization on pain relief during gynecological laparoscopic surgery.

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