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

Comparison of Analgesic Effect of Intrathecal Morphine and Buprenorphine as adjuvants to Bupivacaine for major gynaecological surgery : a Prospective, Randomized Double Blinded Study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/09/036710

Enrollment

Registered

2021-09-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Spinal anaesthesia: Subarachnoid block Injecting opiods intrathecally Control Intervention1: Morphine Buprenorphine: Morphine 100mcg intrathecally with 3.4ml bupivacaine Buprenorphine 6

Eligibility

Inclusion criteria

Inclusion criteria: Major gynaecological surgeries BMI Height more than 150cm Duration of surgery more than60min

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To compare the duration of analgesia using Morphine and Buprenorphine as adjuvants to BupivacaineTimepoint: 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

Measure	Time frame
To compare the associated side effectsTimepoint: Side effects are assessed hourly for 24hrs;To compare the haemodynamics between two groupsTimepoint: 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 onset and duration of motor blockadeTimepoint: The time for the onset of motor blockade is assessed immediately after giving spinal the total duration of the motor blockade is assessed till the motor effect regresses;To compare the onset and duration of sensory blockadeTimepoint: Onset of sensory blockade is assessed from immediately after giving spinal anaesthesia till it reaches the highest level;To compare the sedation between two groupsTimepoint: sedation is assessed hourly after injecting the drug for 12hrs	—

Measure

Time frame

To compare the associated side effectsTimepoint: Side effects are assessed hourly for 24hrs;To compare the haemodynamics between two groupsTimepoint: 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 onset and duration of motor blockadeTimepoint: The time for the onset of motor blockade is assessed immediately after giving spinal the total duration of the motor blockade is assessed till the motor effect regresses;To compare the onset and duration of sensory blockadeTimepoint: Onset of sensory blockade is assessed from immediately after giving spinal anaesthesia till it reaches the highest level;To compare the sedation between two groupsTimepoint: sedation is assessed hourly after injecting the drug for 12hrs

—

Countries

India

Contacts

Public ContactDr K Nisha

chettinad hospital and research institute

knisha19941@gmail.com8903711399

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026