| CTRI Number |
CTRI/2025/10/095602 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
04/10/2025 |
| 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
|
Comparative evaluation of two different doses of oral pregabalin given before surgery on duration of spinal anesthesia and reduction of postoperative pain. |
|
Scientific Title of Study
|
A randomized controlled trial to compare the efficacy of two different doses of pre emptive oral pregabalin on prolongation of spinal anesthesia and attenuation of postoperative pain |
| 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 TEJAS G |
| Designation |
Junior Resident |
| Affiliation |
|
| Address |
Sapthagiri Institute Of Medical Science and Research Centre, Department Of Anaesthesiology, Division: Anaesthesia, Room No. :1,2,3. No.15, Chikkasandra,Hesaraghatta main road,Bengaluru-560090,Karnataka
Bangalore KARNATAKA 560090 India |
| Phone |
9148244979 |
| Fax |
|
| Email |
teju.24.g@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
PRABHA P |
| Designation |
Professor |
| Affiliation |
SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCE AND RESEARCH CENTRE |
| Address |
Sapthagiri Institute Of Medical Science and Research Centre, Department Of Anaesthesiology, Division: Anaesthesia, Room No. :1,2,3. No.15, Chikkasandra,Hesaraghatta main road,Bengaluru-560090,Karnataka
Bangalore KARNATAKA 560090 India |
| Phone |
9448055973 |
| Fax |
|
| Email |
prabhap1510@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
PRABHA P |
| Designation |
Professor |
| Affiliation |
SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCE AND RESEARCH CENTRE |
| Address |
Sapthagiri Institute Of Medical Science and Research Centre, Department Of Anaesthesiology, Division: Anaesthesia, Room No. :1,2,3. No.15, Chikkasandra,Hesaraghatta main road,Bengaluru-560090,Karnataka
Bangalore KARNATAKA 560090 India |
| Phone |
9448055973 |
| Fax |
|
| Email |
prabhap1510@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sapthagiri Institute Of Medical Science and Research Centre, Department Of Anaesthesiology, Division: Anaesthesia, Chikkasandra,Hesaraghatta main road,Bengaluru-560090,Karnataka,India |
|
|
Primary Sponsor
|
| Name |
SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCE AND RESEARCH CENTRE |
| Address |
Sapthagiri Institute Of Medical Science and Research Centre, Department Of Anaesthesiology, Division: Anaesthesia, Room No. :1,2,3. No.15, Chikkasandra,Hesaraghatta main road,Bengaluru-560090,Karnataka |
| Type of Sponsor |
Private 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 TEJAS G |
SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCE AND RESEARCH CENTRE |
SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCE AND RESEARCH CENTRE,DEPARTMENT OF ANAESTHESIA,DIVISION:ANAESTHESIA,ROOM NO: OT1,2,3,No.15,CHIKKASANDRA,HESARAGHATTA MAIN ROAD,BENGALURU-560090,KARNATAKA Bangalore KARNATAKA |
9148244976
teju.24.g@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCE OF MEDICAL SCIENCE AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pregabalin 150mg |
PREGABALIN 150MG WILL BE GIVEN 90 MIN PRE OPERATIVELY. |
| Comparator Agent |
PREGABALIN 75MG |
PREGABALIN 75MG WILL BE GIVEN 90 MIN PRE OPERATIVELY |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA 1 and 2
2.patient scheduled for elective lower abdominal and lower limb surgeries
3.BMI 18 to 35 kg/m2
|
|
| ExclusionCriteria |
| Details |
1.Allergy to pregabalin
2.contraindication to spinal anesthesia,
3.Renal/hepatic dysfunction
4.chronic analgesic use
5.refusal to participate. |
|
|
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 |
1. Duration of sensory block (onset to regression to S1 dermatome).
2. Duration of motor block (onset to Bromage score 0).
3. Time to first rescue analgesic (minutes from block administration to first analgesic
request).
4. Total opioid requirement within 24 hours (tramadol and paracetamol equivalents).
5. Pain intensity using the Visual Analogue Scale (VAS).
6. Side effects (nausea, vomiting, dizziness, sedation, respiratory depression). |
1. Duration of sensory block (onset to regression to S1 dermatome).
2. Duration of motor block (onset to Bromage score 0).
3. Time to first rescue analgesic (minutes from block administration to first analgesic
request).
4. Total opioid requirement within 24 hours (tramadol and paracetamol equivalents).
5. Pain intensity using the Visual Analogue Scale (VAS).
6. Side effects (nausea, vomiting, dizziness, sedation, respiratory depression). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
15/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Postoperative pain remains a significant healthcare challenge globally, with approximately 80% of surgical patients experiencing acute pain, and nearly 50% reporting inadequate pain relief despite advances in pain management techniques. The incidence of moderate-to-severe postoperative pain ranges from 31% to 58% even after hospital discharge, contributing to delayed mobilization, prolonged hospitalization, increased healthcare costs, and potential development of chronic postsurgical pain which affects 20-30% of patients at 6-12 months post-surgery.Lower abdominal surgeries under spinal anesthesia are particularly associated with significant postoperative pain that can impair recovery and patient satisfaction. Current knowledge regarding pregabalin’s optimal dosing for preemptive analgesia in spinal anesthesia remains limited and contradictory. While several studies have demonstrated pregabalin’s efficacy in reducing postoperative pain and opioid consumption, there exists significant variability in dosing regimens ranging from 75mg to 600mg, with no consensus on the optimal dose. Most research has focused on general anesthesia, with limited studies specifically evaluating pregabalin’s effects on spinal anesthesia characteristics. Additionally, direct comparative studies between different pregabalin doses in the context of spinal anesthesia for lower abdominal surgeries are scarce. The mechanisms by which pregabalin prolongs motor and sensory blocks in spinal anesthesia are not fully understood, and there remains uncertainty about the dose-response relationship for optimal analgesic efficacy while minimizing adverse effects. This study aims to bridge this critical knowledge gap by directly comparing two clinically relevant doses of pregabalin (75mg versus 150mg) in patients undergoing lower abdominal surgeries under spinal anesthesia. Such comparative evaluation is essential to establish evidence-based dosing guidelines that maximize analgesic efficacy while minimizing side effects, ultimately improving patient outcomes and optimizing perioperative pain management protocols in this specific surgical population.
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