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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  
Name  Address 
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 
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  
Status 
Not Applicable 
 
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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