| CTRI Number |
CTRI/2025/04/086029 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
30/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing Gabapentin and Magnesium sulphate for pain after lumbosacral spinal fixation surgeries |
|
Scientific Title of Study
|
Comparison of Magnesium Sulphate versus
Gabapentin for post-operative
analgesia in patients undergoing complex
lumbosacral spinal fixation surgery: A
Prospective, Randomized, Double-blinded,
Placebo-controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tanzim Akram |
| Designation |
Junior Resident Doctor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Rishikesh |
| Address |
Department of Anaesthesiology, AIIMS Rishikesh, Virbhadra Road, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7980176727 |
| Fax |
|
| Email |
tanzimt4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Gupta |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Rishikesh |
| Address |
Department of Anaesthesiology, AIIMS Rishikesh, Virbhadra Road, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9811894899 |
| Fax |
|
| Email |
priyanka.anaes@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Gupta |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Rishikesh |
| Address |
Department of Anaesthesiology, AIIMS Rishikesh, Virbhadra Road, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9811894899 |
| Fax |
|
| Email |
priyanka.anaes@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, AIIMS Rishikesh, Level 6, Virbhadra Road, Rishikesh, District: Dehradun, Pincode: 249203, Uttarakhand, India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
LEVEL 6, Department of Anaesthesiology, AIIMS, Shivajinagar, RISHIKESH, UTTARAKHAND, 249203 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Tanzim Akram |
Main OT complex, level 6, AIIMS Rishikesh |
Level 6, Department of Anaesthesiology, AIIMS Rishikesh, Virbhadra Road, Rishikesh
Dehradun
UTTARANCHAL |
7980176727
tanzimt4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M489||Spondylopathy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Capsule Gabapentin |
Patient will receive Capsule Gabapentin 1200mg one hour before surgery |
| Comparator Agent |
Injection Magnesium Sulphate |
Patient will receive Injection Magnesium Sulphate at a dose 50mg/kg over one hour which will be started 15 minutes before the induction of general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA) grade I-II patients undergoing elective lumbosacral spinal fixation surgery (non traumatic spondylopathy)
involving two or more levels. |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patient with known hypersensitivity to either drug
Patient with neuromuscular disease like Myasthenia Gravis
Patients already on Capsule Gabapentin
Pregnancy
Patients with pre-existing significant cardiac, respiratory, hepatic,
renal disease
Patients lost to/not willing to follow up |
|
|
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 |
| Post-operative pain assessment using Numeric Rating Scale for surgical site pain and leg pain (radiculopathy)(NRS) |
At regular intervals during first 24 hour postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intra-operative haemodynamic changes |
During the surgery at regular intervals |
| Opioid consumption |
During surgery and in the first 24 hours after surgery |
| time for Requirement of first rescue analgesia |
In the first 24 hours after surgery |
| Adverse effects of study drugs if any |
Immediate and delayed |
| Time taken for first ambulation |
After surgery (in hours) |
| Number of hospitalisation days |
Post-operative days |
| Quality of life assessment using EuroQoL questionnaire |
At the time of hospital discharge and 30
days follow up using EuroQoL questionnaire |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
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)
|
15/05/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
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 aims to compare the efficacy of Magnesium sulphate and gabapentin, in postoperative analgesia following elective lumbosacral spinal fixation surgery. Patients will be randomized into three groups and allocation concealment will be done using sequentially numbered opaque sealed envelope method. This study will provide insights into the comparative effectiveness of magnesium sulphate and gabapentin in optimizing analgesia and recovery following complex spinal fixation surgery. |