| CTRI Number |
CTRI/2024/05/066857 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2024 |
| 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
|
Evaluation of pregabalin for reduction of postoperative pain after laparoscopic abdominal surgeries |
|
Scientific Title of Study
|
Evaluation of pre-emptive use of pregabalin for attenuation of post operative pain after laparoscopic abdominal surgeries. |
| 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 Shrish Satish Shetty |
| Designation |
Post Graduate Resident in Anaesthesiology |
| Affiliation |
B.J.Medical College and Civil Hospital Ahmedabad |
| Address |
F3, First floor, Department of Anaesthesiology, Civil hospital , Asarwa, Ahmedabad , Gujurat , 380016, INDIA
Ahmadabad
GUJARAT
380016
India |
| Phone |
7567199960 |
| Fax |
|
| Email |
shrishschamp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran B Patel |
| Designation |
Associate Professor(HG) |
| Affiliation |
B.J.Medical College and Civil Hospital Ahmedabad |
| Address |
F3, First floor, Department of Anaesthesiology, Civil hospital , Asarwa, Ahmedabad , Gujurat , 380016, INDIA
Ahmadabad
GUJARAT
380016
India |
| Phone |
9428804290 |
| Fax |
|
| Email |
Kiru4576@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran B Patel |
| Designation |
Associate Professor(HG) |
| Affiliation |
B.J.Medical College and Civil Hospital Ahmedabad |
| Address |
F3, First floor, Department of Anaesthesiology, Civil hospital , Asarwa, Ahmedabad , Gujurat , 380016, INDIA
Ahmadabad
GUJARAT
380016
India |
| Phone |
9428804290 |
| Fax |
|
| Email |
Kiru4576@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, BJ Medical College and Civil Hospital, Ahmedabad |
|
|
Primary Sponsor
|
| Name |
Dr Shrish Satish Shetty |
| Address |
B.j.Medical College ,Asarwa, Ahmedabad |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Government Of Gujarat |
7th , floor, Health and Family Welfare Department , Sachivalay, Gandhinagar, |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shrish Satish Shetty |
B.J. Medical college and civil hospital, Ahmedabad |
Department of Anaesthesia , B.J.Medical College, Asarwa, Ahmedabad, Gujarat
Ahmadabad
GUJARAT |
7567199960
shrishschamp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee, B.J. Medical College and Civil Hospital, Ahmedabad |
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 |
| Intervention |
Pregabalin capsule one hour before the surgery. |
Pregabalin 150 mg before one hour of laparoscopic surgery for attenuation of post operative pain |
| Comparator Agent |
Vitamin B complex one hour before surgery |
Vitamin B complex one tablet as a placebo one hour before surgery and look for post operative pain relief |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Planned surgeries of either sex
2.Patients aged 18 to 60 years
3.ASA Grade I,II,
4.Undergoing elective laparoscopic surgeries under general anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal.
2.ASA 3 and 4.
3.Patients with other lung and cardiac pathologies.
4.Patients with hypertension, uncontrolled diabetes mellitus, systemic infection,,history of malignancy, history of alcohol or drug abuse.
5.Patient with a history of allergy to pregabalin.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the time of requirement for the first dose of rescue analgesic.
|
Pain profile is measured in terms of VAS score postoperatively, at 1st, 2nd, 4th, 6th,12th,24th hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare
1)The amount of rescue analgesic needed postoperatively in first 24 hrs
2) Intraoperative hemodynamic monitoring 3)Postop VAS score
|
Pain profile is measured in terms of VAS score postoperatively, at 1st, 2nd, 4th, 6th,12th,24th hours
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
13/05/2024 |
| 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="0"
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
|
Preemptive analgesia is an antinociceptive treatment that prevents establishment of altered processing of afferent input, which amplifies postoperative pain. Various pharmacological agents and techniques like local infiltration, epidural analgesia, nonsteroidal anti-inflammatory drugs, opioids, Gabapentin, pregabalin, alpha-2 agonist, cox-2 inhibitors are used to produce analgesia. Gabapentinoids are anti-convulsants with membrane stabilizing and anti-nociceptive effects. These drugs bind to the presynaptic a2–d subunit voltage-dependent calcium channel. The anti-nociceptive effect is believed to be related to the reduction of the Ca2+ influx at presynaptic terminals in hyperexcited neurons, which may lead to the reduction of the release of several excitatory neurotransmitters, including glutamate, norepinephrine, substance P, and calcitonin gene-related peptide. Thus, gabapentinoids appear to reduce the hyperexcitability of dorsal horn neurons that is induced by tissue damage. Evidence supporting the postoperative analgesic efficacy of pregabalin is limited to randomized controlled trials in patients undergoing dental surgery, spinal fusion surgery, laparoscopic hysterectomy and day-case gynaecological laparoscopic surgery. Few of these trials has investigated the role of preoperative single-dose administration of pregabalin in attenuating postoperative pain after laparoscopic abdominal surgeries. The present study was therefore designed to evaluate the role of preoperative single dose of pregabalin for attenuating postoperative pain and analgesic consumption in patients undergoing laparoscopic abdominal surgeries. |