| CTRI Number |
CTRI/2019/03/018053 [Registered on: 12/03/2019] Trial Registered Prospectively |
| Last Modified On: |
09/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to find out how well pregabalin and gabapentin when given before surgery provides pain relief after surgery for lower abdominal surgeries done using spinal anaesthesia. |
|
Scientific Title of Study
|
A prospective double blinded control study comparing the efficacy of Pregabalin and Gabapentin as a premedication in influencing postoperative analgesia for lower abdominal surgeries performed under subarachnoid block |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC/2018/435 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pavithra |
| Designation |
PG Resident |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Shri Sathya Sai Medical College and Research Institute
Thiruporur Guduvanchery Main Road
Ammapettai Nellikuppam
Kancheepuram 603108
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9500834405 |
| Fax |
|
| Email |
chocopavithra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinod Krishnagopal |
| Designation |
Professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Shri Sathya Sai Medical College and Research Institute
Thiruporur Guduvanchery Main Road
Ammapettai Nellikuppam
Kancheepuram 603108
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9841557566 |
| Fax |
|
| Email |
vinodkrishnagopal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavithra |
| Designation |
PG Resident |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Shri Sathya Sai Medical College and Research Institute
Thiruporur Guduvanchery Main Road
Ammapettai Nellikuppam
Kancheepuram 603108
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9500834405 |
| Fax |
|
| Email |
chocopavithra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai Medical College and Research Institute |
|
|
Primary Sponsor
|
| Name |
Dr Pavithra |
| Address |
28-2E cee dee yes chennai pattinam,
survey no.360,
thiruporur nellikuppam road,
ammapettai village,
nellikuppam-603108,
kancheepuram district,
tamilnadu, india.
|
| Type of Sponsor |
Other [Self] |
|
|
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 pavithra |
Shri Sathya Sai Medical College and Research Institute |
Shri Sathya Sai Medical College and Research Institute
Tiruporur Guduvancherry Main Road
Ammapettai
Chengalpet Taluk Kancheepuram District Nellikuppam
Tamil Nadu 603108
Kancheepuram
TAMIL NADU |
9500834405
chocopavithra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Human Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K35-K38||Diseases of appendix, (2) ICD-10 Condition: K40-K46||Hernia, (3) ICD-10 Condition: N80-N98||Noninflammatory disorders of female genital tract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gabapentin |
600mg Given per orally once 2 hours before spinal anaesthesia. |
| Comparator Agent |
placebo drug |
1 Capsule Given per orally once 2 hours before spinal anaesthesia. |
| Intervention |
Pregabalin |
150mg Given per orally once 2 hours before spinal anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both sexes consenting for lower abdominal surgeries under subarachnoid block
BMI between18-25 kg/m2
|
|
| ExclusionCriteria |
| Details |
ASA III and above physical status
Pregnancy and Lactating mother
Known psychiatric disorder
Patients with cardiac disease or chronic kidney disease
All neuropathies
coagulopathies
patient refusal for spinal anaesthesia
Failed spinal
inadequate level of block
high spinal
prolonged surgery
Patient with allergic to the drug
Patient who are already on Pregabalin or 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 |
| To compare the intensity of postoperative pain in 3 groups by numeric pain intensity scale (NPIS) for 24 hours. |
postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the time interval between subarachnoid block and first rescue analgesic |
from intraoperative peroid till postoperative peroid |
| To evaluate total dosage of rescue analgesics given in first 24 hours. |
postoperative period |
| To assess the sedation score of the drug |
intraoperative and postoperative peroid |
| To evaluate the presence of any adverse effects of drug (diplopia, nausea, vomiting, diarrhoea, confusion, respiratory depression). |
intraoperative and postoperative peroid |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/03/2019 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomised double blinded control study comparing the efficacy of oral pregabalin and gabapentin as a premedication in influencing postoperative analgesia for 72 patients posted for lower abdominal surgeries performed under subarachnoid block. The primary objective would be to compare the intensity of postoperative pain in 3 groups by numeric pain intensity scale (NPIS) for 24 hours.The secondary objectives are to compare the time interval between subarachnoid block and first rescue analgesics,To evaluate total dosage of rescue analgesics given in first 24 hours,To assess the sedation score of the drug and To evaluate the presence of any adverse effects of drug (diplopia, nausea, vomiting, diarrhoea, confusion, respiratory depression). |