| CTRI Number |
CTRI/2025/11/097810 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effectiveness of pain relief between Injection Magnesium Sulphate and Injection Butorphanol used as additives to Injection Bupivacaine heavy for spinal anesthesia in women undergoing lower abdominal gynecological surgery. |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF INTRATHECAL MAGNESIUM SULPHATE VERSUS INTRATHECAL BUTORPHANOL AS ADJUVANT TO HYPERBARIC BUPIVACAINE IN ELECTIVE INFRAUMBILICAL GYNAECOLOGICAL SURGERY. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poushali De |
| Designation |
Senior Resident |
| Affiliation |
North Bengal Medical College and Hospital |
| Address |
Department of Anesthesiology,North Bengal Medical College and Hospital,Sushrutanagar, District-Darjeeling.West Bengal.
Darjiling
WEST BENGAL
734012
India |
| Phone |
7547929127 |
| Fax |
|
| Email |
drdeanaesth21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhishek Ganguly |
| Designation |
Assistant Professor |
| Affiliation |
North Bengal Medical College and Hospital |
| Address |
Department of Anesthesiology, North Bengal Medical College and Hospital,Sushrutanagar,District- Darjeeling. West Bengal.
Darjiling
WEST BENGAL
734012
India |
| Phone |
9831404520 |
| Fax |
|
| Email |
abhi_here4u@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek Ganguly |
| Designation |
Assistant Professor |
| Affiliation |
North Bengal Medical College and Hospital |
| Address |
Department of Anesthesiology, North Bengal Medical College and Hospital,Sushrutanagar,District -Darjeeling.West Bengal.
Darjiling
WEST BENGAL
734012
India |
| Phone |
9831404520 |
| Fax |
|
| Email |
abhi_here4u@yahoo.com |
|
|
Source of Monetary or Material Support
|
| North Bengal Medical College and Hospital,Sushrutanagar ,Darjeeling,West Bengal,734012 |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology, North Bengal Medical College and Hospital |
| Address |
NBMCH,Sushrutanagar,Darjeeling,
West Bengal, 734012 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ABHISHEK GANGULY |
NORTH BENGAL MEDICAL COLLEGE ANAESTHESIOLOGY DEPARTMENT |
PAC room,Gynecology OT Complex, PACU room,Department Of Anesthesiology.
Darjiling
WEST BENGAL |
9831404520
abhi_here4u@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified, (2) ICD-10 Condition: N809||Endometriosis, unspecified, (3) ICD-10 Condition: N819||Female genital prolapse, unspecified, (4) ICD-10 Condition: N926||Irregular menstruation, unspecified, (5) ICD-10 Condition: N839||Noninflammatory disorder of ovary,fallopian tube and broad ligament, unspecified, (6) ICD-10 Condition: N832||Other and unspecified ovarian cysts, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTRATHECAL BUTORPHANOL AS ADJUVENT TO HYPERBARIC BUPIVACAINE IN ELECTIVE INFRAUMBILICAL GYNAECOLOGICAL SURGERY |
50 Patients of ASA I or II physical status, aged 20-55year , undergoing elective Gynecological surgery were divided into 2 groups,group M and group B.Group B will receive 3.0ml of 0.5% Bupivacaine heavy +0.25ml(250mcg) of Inj. Butorphanol(1mg/ml)+ 0.25ml of Normal Saline. |
| Comparator Agent |
INTRATHECAL MAGNESIUM SULPHATE AS ADJUVENT TO HYPERBARIC BUPIVACAINE IN ELECTIVE INFRAUMBILICAL GYNAECOLOGICAL SURGERY. |
50 Patients of ASA I or II physical status, aged 20-55year , undergoing elective Gynecological surgery were divided into 2 groups – Group M will receive 3.0 ml of 0.5% Bupivacaine heavy +0.2ml(100mg) of 50% Inj. Magnesium Sulphate +0.3 ml Normal Saline. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Female patient posted for elective gynecological surgery
Age 20 to 55yrs
ASA 1 ,2
BMI 18.5 to 24.9
|
|
| ExclusionCriteria |
| Details |
Refusal of patients to undergo this study
History of hypersensitivity to any of the medications used in the study
Active neurological, cardiac, respiratory, blood dyscrasias, renal disease, any contraindication of subarachnoid block
Patients with dyselectrolytemias
Surgery duration of more than 3 hrs.
Spinal deformity
Pregnant patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time of sensory and motor block,total duration of motor and sensory block,time for first rescue analgesia. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of the block both sensory and motor (modified Bromage) and VAS scale for requirement of rescue analgesia.Monitoring of vital Spo2, SBP, DBP, PR
Comparison of any other notifiable adverse event like desaturation, severe hypotension, bradycardia etc. as well as any sedation, cardiac arrythmias, pruritus, hypersensitivity reaction.
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective, institution based, double blind, randomized comparative study. Place of study is PAC room and Gynecology OR at North Bengal Medical College.Period of study is one year.This study will compare the onset and duration of motor and sensory block due to addition of Magnesium Sulphate or Butorphanol as adjuvant added to Bupivacaine heavy in admitted patients undergoing gynecological surgeries under spinal anesthesia.In a Government Medical College in a hilly peripheral district in India like North Bengal Medical College, there is a lack of availability of commonly used opioids like Morphine , Meperidine and Fentanyl whereas agents like Magnesium Sulphate and Butorphanol are readily available for use as adjuvant in spinal anesthesia.However there is dearth of knowledge in comparison between these two agents when used as adjuvant in spinal anesthesia.Our study aims to find a direct comparative data between Butorphanol and Magnesium Sulphate as well as find out any complications as well as side effects of using these drugs as adjuvant in spinal anesthesia.Our hypothesis is that Butorphanol will be more effective as adjuvant in spinal anesthesia than Magnesium Sulphate in gynecological surgeries, both in terms of intraoperative as well as post operative pain relief.Calculated sample size is fifty patients with twenty five in each group.The time of sensory and motor block, duration of sensory and motor block, time for first rescue analgesia, timed measurement of vitals, perioperative VAS score and any postoperative complications. |