| CTRI Number |
CTRI/2021/09/036710 [Registered on: 21/09/2021] Trial Registered Prospectively |
| Last Modified On: |
06/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Analgesic Effect of Intrathecal Morphine and Buprenorphine as adjuvants to Bupivacaine for Major Gynaecological Surgery : a Prospective, Randomized Double Blinded study. |
|
Scientific Title of Study
|
Comparison of Analgesic Effect of Intrathecal Morphine and Buprenorphine as adjuvants to Bupivacaine for major gynaecological surgery : a Prospective, Randomized Double Blinded Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Lailu Mathews |
| Designation |
professor |
| Affiliation |
Chettinad hospital and research institute |
| Address |
C Block
Department of Anaesthesia
Chettinad health city
Rajiv Gandhi Salai
kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9443535910 |
| Fax |
|
| Email |
lailu.mathews@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Nisha |
| Designation |
postgraduate |
| Affiliation |
chettinad hospital and research institute |
| Address |
A6 villa 1st floor
chettinad health city
chettinad university
Rajiv Gandhi salai
kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
8903711399 |
| Fax |
|
| Email |
knisha19941@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Nisha |
| Designation |
postgraduate |
| Affiliation |
chettinad hospital and research institute |
| Address |
E block
A6 villa 1st floor
chettinad health city
Rajiv Gandhi Salai
Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
8903711399 |
| Fax |
|
| Email |
knisha19941@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Health City,
Rajiv Gandhi Salai,
Kelambakkam - 603 103,
Chengalpattu District, Chennai,
Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
chettinad health city |
| Address |
Chettinad Health City,
Rajiv Gandhi Salai,
Kelambakkam - 603 103,
Chengalpattu District, Chennai,
Tamil Nadu, India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| chettinad health city |
chettinad hospital and research institute
kelambakkam |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| K Nisha |
chettinad hospital |
C Block,Department of A naesthesia,
Rajiv Gandhi Salai,
Kelambakkam - 603 103,
Chengalpattu District, Chennai,
Tamil Nadu, India
Kancheepuram
TAMIL NADU |
8903711399
knisha19941@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chettinad academy of research and education human ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Morphine
Buprenorphine |
Morphine 100mcg intrathecally with 3.4ml bupivacaine
Buprenorphine 60mcg intrathecally with 3.4ml bupivacaine |
| Intervention |
Spinal anaesthesia |
Subarachnoid block
Injecting opiods intrathecally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Major gynaecological surgeries
BMI<35Kg/m2
Height more than 150cm
Duration of surgery more than60min |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| 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
the total duration of the motor blockade is assessed till the motor effect regresses |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |