| CTRI Number |
CTRI/2024/11/076206 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| 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
|
To know the postoperative analgesic effect of oral pregablin and oral clonidine in lower limb surgeries in spinal anaesthesia |
|
Scientific Title of Study
|
To Compare Postoperative Analgesic Effect of Oral Pregabalin versus Oral Clonidine in Lower Limb Surgeries Under Spinal Anaesthesia |
| 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 Anita Kumari |
| Designation |
Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9815632909 |
| Fax |
|
| Email |
sgrdanaesthesia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja abbi |
| Designation |
Associate Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
8968088773 |
| Fax |
|
| Email |
pooja.monga259@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Navdeep Kumar |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9878614807 |
| Fax |
|
| Email |
navdeepkumar149@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar, Punjab, India. 143001 |
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar, Punjab, India. 143001 |
| 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 Ruchi Gupta |
Sri Guru Ram Das Institute of Medical Sciences and Research |
Main OT, Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research
Amritsar
PUNJAB |
9814320805
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGRD Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Analgesic effect of drugs |
Each group will be given the study drug orally 1 hr. before procedure:
Group A – 150mcg of oral clonidine
Group B - 150mg of oral pregabalin
Group C – oral multivitamin. |
| Intervention |
Spinal Anaesthesia |
All the patients will received 3ml 0.5% hyperbaric bupivacaine intrathecally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. American society of anesthesiologist class I, class II patients aged 18-65
years of either sex.
2. Patients posted for lower limb surgeries under spinal anesthesia |
|
| ExclusionCriteria |
| Details |
1. Patients with hypersensitivity to study drugs
2. Patients suffering from central nervous system disorder and coagulation
disorders
3. Contraindications to regional anesthesia such as anatomic disorders of spine,
shock, local site infections, peripheral neuropathy
4. Opioid dependents
5. Patient suffering from chronic pain conditions |
|
|
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 |
Effectiveness of oral pregabalin, oral clonidine and placebo
on postoperative analgesia in lower limb surgeries under spinal anesthesia. |
from the end of surgery till 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Requirement of rescue analgesics in 24hrs post operatively
among all the three groups and Hemodynamic changes.
|
from the end of surgery till 24 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/11/2024 |
| 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 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
|
Background: Effective postoperative pain management is crucial for optimal
recovery in lower limb surgeries performed under spinal anesthesia. Pregabalin and
clonidine are both known for their analgesic properties, but their comparative
effectiveness in this specific context remains to be rigorously evaluated. Objective: This study aims to compare the postoperative analgesic effects of oral
pregabalin versus oral clonidine in patients undergoing lower limb surgeries under
spinal anesthesia. Methods: A randomized controlled trial will be conducted with patients scheduled for
elective lower limb surgeries under spinal anesthesia allocated to receive either oral
pregabalin or oral clonidine preoperatively. Postoperative pain will be assessed at
regular intervals, supplemented by evaluation of additional analgesic requirements and
monitoring of adverse effects associated with each treatment.
Outcome: Findings from this study will provide valuable insights into the relative
efficacy and safety profiles of oral pregabalin and oral clonidine for postoperative pain
management in lower limb surgeries under spinal anesthesia. |