| CTRI Number |
CTRI/2025/08/092240 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| 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
|
Study to see if a pain relief medicine can also improve sleep after surgery for leg fractures. |
|
Scientific Title of Study
|
Effect of Gabapentin on sleep quality and post operative pain relief in patients undergoing lower limb trauma 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 |
Dr Vanita Ahuja |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital Chandigarh , Sector 32-B |
| Address |
Department of Anaesthesia and Intensive Care,Government Medical College and Hospital Chandigarh , Sector 32-B
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121649 |
| Fax |
|
| Email |
vanitaahujameetings2020@gmail.con |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vanita Ahuja |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital Chandigarh , Sector 32-B |
| Address |
Department of Anaesthesia and Intensive Care,Government Medical College and Hospital Chandigarh , Sector 32-B
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121649 |
| Fax |
|
| Email |
vanitaahujameetings2020@gmail.con |
|
Details of Contact Person
Public Query
|
| Name |
Riya Ahuja |
| Designation |
Postgraduate junior resident |
| Affiliation |
Government Medical College and Hospital Chandigarh , Sector 32-B |
| Address |
Department of Anaesthesia and Intensive Care,Government Medical College and Hospital Chandigarh , Sector 32-B
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9465468932 |
| Fax |
|
| Email |
riya20ahuja20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital Chandigarh, Sect 32-B |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Intensive Care |
| Address |
Department of Anaesthesia and Intensive Care, Government Medical College and Hospital Chandigarh , Sect 32-B |
| 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 Vanita Ahuja |
Government Medical College and Hospital ,Chandigarh |
Department of Anaesthesia and Intensive Care, Level-5, Government Medical College and Hospital ,Chandigarh , Sector 32-B
Chandigarh
CHANDIGARH |
9646121649
vanitaahujameetings2020@mail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee, Government Medical College and Hospital Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M249||Joint derangement, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gabapentin |
Patients will be given 300mg Gabapentin 2 hours before surgery and 300mg at 12 hours after surgery |
| Comparator Agent |
Placebo |
Patients will be given placebo drug 2 hours before surgery and 12 hours after surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18-65 years
2.American Society of Anaesthesiologists (ASA) physical status I and II
3.Lower limb surgery following trauma less than three months
4.Duration of surgery less than equal to 4 hours |
|
| ExclusionCriteria |
| Details |
1. Patients having head injury and/or polytrauma
2. Contraindications to spinal anaesthesia
3. Contraindications to Gabapentin
4. Pregnant and lactating women
5. Patients not able to understand VAS or PSQI scale
6. Patients having history of substance abuse
7. Patients with preexisting sleep disorders
8. Patients already on Gabapentin |
|
|
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 |
Sleep quality using PSQI sleep score
|
48 hours after surgery in ward |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Sleep quality using PSQI sleep score
2.Postoperative pain relief using VAS score
3. Haemodynamics
4. Ramsay sedation score
5. Total cumulative rescue analgesia (Diclofenac) consumed
6. Total cumulative rescue analgesia(tramadol) consumed |
1.Preoperative ,24 hours after surgery
2.Preop, PACU, 4,8,12,24 and 48 hours
3. Preop, PACU, 4,8,12,24 and 48 h
4. Preop,PACU, 4,8,12,24 and 48 h
5. Preop, PACU, 4,8,12,24 and 48 h
6. Preop PACU, 4,8,12,24 and 48 h |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
20/08/2025 |
| 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 will evaluate the effect of Gabapentin on sleep quality and postoperative pain relief in patients undergoing lower limb trauma surgery.Patients experience poor sleep and significant pain after lower limb trauma surgery.Gabapentin has already been used for treatment of neuropathic pain with the benefit of reduction in opioid requirements and improving function outcomes and sleep.We hypothesise that there is a difference in the response in terms of sleep scores and postoperative pain relief with the use of Gabapentin compared to a placebo drug. |