A clinical trial to compare the effects of two drugs, ropivacaine and levobupivacaine in patients undergoing cesarean section under spinal anaesthesia

Phase 2

Not yet recruiting

• Conditions: Encounter for cesarean delivery without indication,

• Registration Number: CTRI/2023/09/058070
• Lead Sponsor: Niyaz Abdul Salam

Brief Summary

Spinal anesthesia has been a popular method of anaesthesia for short, lower abdominal surgeries. Hyperbaric racemic bupivacaine is commonly used for spinal anaesthesia due to its long duration of action and combined motor and sensory blockade. However there are other preparations which can be used for the same with its own advantages and disadvantages.

The impetus for the development of the newer stereoselective, single enantiomer amide local anaesthetic agents, ropivacaine and levobupivacaine, came from reports of fatal cardiac toxicity in pregnant women receiving epidural bupivacaine and etidocaine for Caesarean section. Although these concerns are not clinically relevant to spinal anaesthesia because of the smaller doses required, there has, nevertheless, been interest in the potential of these agents for intrathecal use.

Intrathecal use of hyperbaric LA agents has become more popular as they produce predictable block characteristics and reliable SA. Ropivacaine, a newer amino-amide local anesthetic (LA) agent similar to bupivacaine in chemical structure, but 30-40% less potent than bupivacaine has been well-studied for spinal anesthesia (SA). The preliminary studies evaluated the efficacy and safety of isobaric ropivacaine for neuraxial blockade.

Intrathecal ropivacaine was found to be safe, having shorter duration of action than bupivacaine and lesser incidence of transient neurological symptoms (TNS) as compared with intrathecal lignocaine.

Another formulation of a local anesthetic, i.e., hyperbaric levobupivacaine is being made more available in India. It is known that levobupivacaine has a lower propensity to cause hypotension and bradycardia and causes early motor recovery. This study aims to compare the effects of hyperbaric ropivacaine and hyperbaric levobupivacaine on its use in pregnant women during elective LSCS. The new introduction of hyperbaric levobupivacaine in India and the lacunae in literature with respect to its comparison with hyperbaric ropivacaine, in terms of hemodynamic parameters, justifies the need for this study

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-09-25
• Study Start: 2023-10-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• ASA physical status I and II.
• Age between 20 to 40 years.
• Weight ranging from 70-90kg Height ranging from 155-185cm (5ft to 6ft) Patients undergoing elective LSCS under spinal anesthesia Provides Consent.

Exclusion Criteria

• Patient undergoing emergency surgery.
• Patient who are unable to give consent.
• Patient with obstetric complications Patient with suspected fetal compromise Coagulopathy Patients who do not fulfill inclusion criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare hyperbaric ropivacaine to hyperbaric levobupivacaine with respect to hemodynamic responses’; blood pressure, heart rate and mean arterial pressure in elective LSCS cases.	2,4,6,8,10,15,30,45,60,90 minutes.

Secondary Outcome Measures

Name	Time	Method
To compare the efficacy of spinal anaesthesia with respect to onset, duration and level of block with hyperbaric ropivacaine and hyperbaric Levobupivacaine in elective LSCS cases.	The assessments of sensory block to pinprick will be performed at 2, 4, 6, 8, 10, and 15 min after the intrathecal injection.

Trial Locations

Locations (1)

KLES Dr Prabhakar Kore Hospital and Medical Research Centre; 🇮🇳 Belgaum, KARNATAKA, India

KLES Dr Prabhakar Kore Hospital and Medical Research Centre

🇮🇳Belgaum, KARNATAKA, India

Niyaz Abdul Salam

Principal investigator

9972673892

niyazsalam7@gmail.com