| CTRI Number |
CTRI/2025/07/090188 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain relief after surgery |
|
Scientific Title of Study
|
EFFECTIVENESS OF TRAMADOL AND KETAMINE AS ADJUVANTS TO BUPIVACAINE FOR INCISIONAL INFILTRATION FOR POSTOPERATIVE ANALGESIA FOLLOWING MAJOR ABDOMINAL SURGERY UNDER GENERAL ANESTHESIA |
| 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 Darotikumari Sudhirbhai Patel |
| Designation |
Resident Doctor |
| Affiliation |
Gujarat cancer and Research institute,BJMC |
| Address |
Anaesthesia department,
5th floor,
Gujarat cancer and research institute, Ahmedabad
Civil Hospital Campus,Asarwa,Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9737935099 |
| Fax |
|
| Email |
darotipatel2498@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rekha N Solanki |
| Designation |
Associate Professor |
| Affiliation |
Gujarat cancer and Research institute,BJMC |
| Address |
Anaesthesia department,
5th floor,
Gujarat cancer and research institute, Ahmedabad
Civil Hospital Campus,Asarwa,Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825469907 |
| Fax |
|
| Email |
rnsbaps@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Darotikumari Sudhirbhai Patel |
| Designation |
Resident Doctor |
| Affiliation |
Gujarat cancer and Research institute,BJMC |
| Address |
Anaesthesia department, 5th floor,Gujarat cancer and research institute,Ahmedabad
Civil Hospital Campus,Asarwa,Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9737935099 |
| Fax |
|
| Email |
darotipatel2498@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college affilitaed GCRI,Ahmedabad-380016,Gujarat,India |
|
|
Primary Sponsor
|
| Name |
Gujarat Cancer and research institute |
| Address |
Ahmedabad,380016,Gujarat India |
| Type of Sponsor |
Government 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 Darotikumari Sudhirbhai Patel |
Gujarat Cancer and Research InstituteAhmedabad |
Gujarat Cancer and Research Institute,Anaesthesia department,5th floor,C wing
Ahmadabad
GUJARAT |
09737935099
darotipatel2498@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Gujarat Cancer and Research Institute ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: C574||Malignant neoplasm of uterine adnexa, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
incisional infilteration |
Duration of the study is one and a half year |
| Comparator Agent |
Tramadol and Ketamine with bupivacaine |
Local Infiltration at the end of surgery
Subcutaneous Tramadol 1 mg per kg mixed with 0.25 percentage of Bupivacaine 0.7mg per kg (diluted to 20ml with 0.9 percentage NS) (N = 40)
comparison with Local Infiltration at the end of surgery
Subcutaneous Ketamine 1mg per kg mixed with 0.25 percentage of Bupivacaine 0.7mg per kg (diluted to 20ml with 0.9 percentage NS) (N = 40)
Duration of study: one and a half year
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Open abdomibal surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Uncotrolled cardio respiratory disorders
Altered hepatorenal function
Refusal to participate
Allergic to study drugs
Psychological problems
long term opioid users
BMI more than 30 kilogram per meter square |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Compare post operative pain score
|
0 hr, 2 hr, 4 hr, 6 hr, 12 hr, 18 hr, 24 hrs after Infiltration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare duration of analgesia
To compare post-operative rescue analgesic requirements
To compare hemodynamic
To compare adverse effect
|
0 hr, 2 hr, 4 hr, 6 hr, 12 hr, 18 hr, 24 hrs after Infiltration |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Overnight fasting All patient will be premedicated with Tab lorazepam (1 mg) at night before surgery. Preoperative patient will be informed about Numeric Rating Scale for pain. Local Infiltration at the end of surgery. ØGroup-1 : Subcutaneous Tramadol 1mg/kg mixed with 0.25% of Bupivacaine 0.7mg/kg (diluted to 20ml with 0.9% NS) (N = 40) ØGroup-2 : Subcutaneous Ketamine 1mg/kg mixed with 0.25% of Bupivacaine 0.7mg/kg (diluted to 20ml with 0.9% NS) (N = 40) Standard monitor Standard General Anaesthesia with proper size cuffed oral endotracheal tube. Intra-Operative monitoring - HR, ECG, BP, SPO2, ETCO2, Urine output, Temperature |