| CTRI Number |
CTRI/2025/08/093180 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing Two Medicines, Tramadol and Tapentadol, Given Before Surgery to Reduce Pain After Gallbladder Removal |
|
Scientific Title of Study
|
Comparison of oral Tramadol and oral Tapentadol as pre-emptive analgesic on post operative analgesia in laparoscopic cholecystectomy under general 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 |
Manpreet Kaur |
| Designation |
Junior Resident |
| Affiliation |
GMCH, Sector 32, Chandigarh |
| Address |
Level 5, Block D, Department of Anaesthesia and Intensive care, GMCH, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
07009802985 |
| Fax |
|
| Email |
minik401@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manpreet Singh |
| Designation |
Professor |
| Affiliation |
GMCH, Sector 32, Chandigarh |
| Address |
Level 5, Block D, Department of Anaesthesia and Intensive Care, GMCH, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121503 |
| Fax |
|
| Email |
manpreetdawar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manpreet Kaur |
| Designation |
Junior Resident |
| Affiliation |
GMCH, Sector 32, Chandigarh |
| Address |
Level 5, Block D, Department of Anaesthesia and Intensive care, GMCH, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
07009802985 |
| Fax |
|
| Email |
minik401@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, Level 5, block D,Government Medical College and Hospital, sector-32 , Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive Care,Level 5, Block D, GMCH, Chandigarh, Pincode 160030, 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 Manpreet Kaur |
Government Medical College and Hospital |
Level 5, Block D, Department of Anaesthesia and Intensive care, GMCH, Chandigarh
Chandigarh
CHANDIGARH |
7009802985
minik401@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(GMCH, Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Tramadol |
Oral Tramadol 100 mg, 1hr before surgery will be given pre emptively and compared with Oral Tapentadol over various timelines for post operative analgesia in laparoscopic cholecystectomy under general anaesthesia. The study will be terminated after 24 hr of surgery completion or when the rescue analgesics are administered to the patient. |
| Comparator Agent |
Oral Tapentadol |
Oral Tapentadol 50 mg, 1 hr before surgery will be given pre emptively and compared with Oral Tramadol over various timelines for post operative analgesia in laparoscopic cholecystectomy under general anaesthesia. The study will be terminated after 24 hr of surgery completion or when the rescue analgesics are administered to the patient. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA class I or II
2. Age: 18 to 70 years, either sex
3. Body mass index (BMI) of 18-35 kg/m2
4. Patients undergoing elective cholecystectomy under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Major co-existing medical illness (especially severe asthma/COPD, repeat hernia surgery,
epilepsy, uncontrolled hypertension or diabetes, liver or renal disease)
2. Patients with paralytic ileus, patients on antidepressants (to avoid risk of developing
serotonin syndrome)
3. Known hypersensitivity to any of the study medications
4. Patients that had conversion to open surgery after laparoscopic visualization.
5. Known opioid abusers and patients on opioid antagonist. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess and compare the post laparoscopic cholecystectomy analgesia after use of oral
Tramadol or oral Tapentadol preemptively before induction of anaesthesia. using Visual
Analogue Scale (0- 10).
2. To compare the adverse effects after use of oral Tramadol or oral Tapentadol
preemptively before induction of anaesthesia in patients of laparoscopic cholecystectomy.
3. Time of rescue analgesia administered |
After shifting to PACU for postoperative pain, sedation, nausea and vomiting at 0 hour, 2 hours, 6 hours and after 24 hours post-surgery.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the hemodynamic parameters like heart rate (HR), systolic blood pressure
(SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), pulse oximetry
(SpO2 ) and EtCO2 |
Baseline, after induction, post-intubation
at 1, 5 and 10 min (T1, T5 and T10) , post-surgery when patient is shifted to PACU i.e 0
hour, 2 hours, 6 hours and after 24 hours post-surgery |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
23/10/2025 |
| 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="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
|
This study aims to evaluate and compare the analgesic efficacy of oral Tramadol and Tapentadol when administered preemptively prior to anaesthesia induction in patients undergoing laparoscopic cholecystectomy. the objective is to determine which agent provides superior postoperative pain control. Pain intensity will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain ) to 10 (worst imaginable pain ), at specified postoperative intervals: immediately upon arrival at PACU and at 2, 6, 24 hour post operatively. the study will also evaluate the incidence of adverse effects, time of first rescue analgesia, and overall tolerability profile of each medication. Furthermore, perioperative hemodynamic parameters - including heart rate, systolic and diastolic blood pressure, mean arterial pressure, oxygen saturation (SpO2), end tidal carbon dioxide (EtCO2) - will be monitored at pre defined intraoperative and postoperative time points to assess physiological stability and potential drug related influences. |