Comparison of Analgesic Effect of Intrathecal Morphine and Buprenorphine as adjuvants to Bupivacaine for Major Gynaecological Surgery : a Prospective, Randomized Double Blinded study.

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/09/036710
• Lead Sponsor: chettinad health city

Brief Summary

The primary aim of this study is to compare the analgesic effect of morphine and buprenorphine as adjuvants to bupivacaine.Morphine 100mcg is added with 3.4ml of 0.5 % H bupivacaine in one sample and buprenorphine 60mcg is addded with 0.5% H bupivacine in another sample and the ana;lgesic effect of both the samples are compared. IN ADDITION TO THIS THE ONSET OF SENSORY AND MOTOR BLOCKADE ,THE SEDATION EFFECT AND ADVERSE EFFECTS ARE ALSO compared

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-10
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

Major gynaecological surgeries BMI<35Kg/m2 Height more than 150cm Duration of surgery more than60min.

Exclusion Criteria

Spine deformity Patients not willing for spinal anaesthesia Coagulopathy local infection at site of injection Increased intracranial pressure Patient allergic or sensitive to local anaesthetic agents.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the duration of analgesia using Morphine and Buprenorphine as adjuvants to Bupivacaine	The duration of analgesia is noted for 24hrs from the time of injection of drug to the time when the patient complaints of pain

Secondary Outcome Measures

Name	Time	Method
To compare the onset and duration of sensory blockade	Onset of sensory blockade is assessed from immediately after giving spinal anaesthesia till it reaches the highest level
To compare the onset and duration of motor blockade	The time for the onset of motor blockade is assessed immediately after giving spinal
To compare the haemodynamics between two groups	All haemodynamic parameters are measured 5min once for first half an hour after injecting drug then at an interval of 15 min for 4hrs.Then at an interval of 1hour for 12hrs .Then at an interval of 3hrs for 24 hours
To compare the sedation between two groups	sedation is assessed hourly after injecting the drug for 12hrs
To compare the associated side effects	Side effects are assessed hourly for 24hrs

Trial Locations

Locations (1)

chettinad hospital; 🇮🇳 Kancheepuram, TAMIL NADU, India

chettinad hospital

🇮🇳Kancheepuram, TAMIL NADU, India

K Nisha

Principal investigator

8903711399

knisha19941@gmail.com