| CTRI Number |
CTRI/2026/02/104309 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study Comparing Two medicine for Pain Relief After Open Gallbladder Surgery |
|
Scientific Title of Study
|
Comparison of postoperative analgesia between intramuscular tramadol vs intranasal tapentadol following open cholecystectomy: An open label randomized clinical triaL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRAJNAPARMITA SAHA |
| Designation |
FINAL YEAR RESIDENT |
| Affiliation |
AGARTALA GOVERNMENT MEDICAL COLLAGE |
| Address |
AGARTALA GOVERNMENT MEDICAL COLLAGE , AGARTALA,TRIPURA
West Tripura
TRIPURA
799006
India |
| Phone |
7085826059 |
| Fax |
|
| Email |
prajnaparmitas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PRAJNAPARMITA SAHA |
| Designation |
FINAL YEAR RESIDENT |
| Affiliation |
AGARTALA GOVERNMENT MEDICAL COLLAGE |
| Address |
AGARTALA GOVERNMENT MEDICAL COLLAGE , AGARTALA,TRIPURA
West Tripura
TRIPURA
799006
India |
| Phone |
7085826059 |
| Fax |
|
| Email |
prajnaparmitas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRAJNAPARMITA SAHA |
| Designation |
FINAL YEAR RESIDENT |
| Affiliation |
AGARTALA GOVERNMENT MEDICAL COLLAGE |
| Address |
AGARTALA GOVERNMENT MEDICAL COLLAGE , AGARTALA,TRIPURA
West Tripura
TRIPURA
799006
India |
| Phone |
7085826059 |
| Fax |
|
| Email |
prajnaparmitas@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PRAJNAPARMITA SAHA |
| Address |
AGARTALA GOVERNMENT MEDICAL COLLAGE WEST TRIPURA |
| 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 Debasis Ray |
Agartala Government Medical college |
DEPARTMENT OF PHARMACOLOGY
West Tripura
TRIPURA |
9436125100
contactdebasisray@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Clinical Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K819||Cholecystitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
intramuscular tramadol |
intramuscular tramadol 100 mg thrice daily for 72 hours. |
| Intervention |
intranasal tapentadol |
intranasal tapentadol 45 mg that is 22.5 mg in each nostril thrice daily for 72 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All the newly diagnosed Cholecystitis patients undergoing Open Cholecystectomy with American Society of Anesthesiologists (ASA) physical status classification 1 & 2 at General Surgery Department of AGMC, in the age group of 18 years and above, shall be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients with ASA class 3 or above status.
- Patients below 18 years of age
- Patients on immunosuppressive drugs.
- Patients unwilling for giving consent.
- Pregnant and lactating women.
- Subjects with Chronic Kidney Disease
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
determine and compare the degree of analgesia of intramuscular Tramadol and intranasal Tapentadol in post operative pain management following Open Cholecystectomy.
|
determine and compare the degree of analgesia of intramuscular Tramadol and intranasal Tapentadol in post operative pain management following Open Cholecystectomy 2 hours after each dose for 72 hours by visual analouge score
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to demonstrate any adverse event by the drugs used. |
assessment will be done after 2 hours of each dose for 72 hours. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/01/2028 |
| 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="0"
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
|
The aim of the study is to compare the efficacy of intramuscular Tramadol and intranasal Tapentadol in postoperative pain management following open cholecystectomy The primary objective is to determine and compare the degree of analgesia by intramuscular Tramadol and intranasal Tapentadol using VAS score The secondary objective is to assess and compare the adverse events of intramuscular Tramadol and intranasal Tapentadol among the study participants
This is an experimental study designed as an open label parallel group randomized clinical trial The study will be conducted in the Department of Surgery and the Department of Pharmacology AGMC and GBP Hospital over a duration of six months The study population includes cholecystitis patients undergoing open cholecystectomy in the General Surgery Department AGMC and GBP Hospital Inclusion criteria include newly diagnosed cholecystitis patients aged eighteen years and above undergoing open cholecystectomy with ASA physical status class one and two Exclusion criteria include ASA class three and above age below eighteen years use of immunosuppressive drugs unwillingness to give consent pregnancy lactation and chronic kidney disease
After randomization one group will receive intramuscular Tramadol one hundred milligram every eight hours for seventy two hours and the other group will receive Tapentadol nasal spray forty five milligram every eight hours for seventy two hours VAS score will be recorded two hours after each dose from the first dose on postoperative day zero up to the tenth dose on postoperative day three Rescue analgesia with injection Diclofenac sodium seventy five milligram intramuscular will be given if VAS score is five or more Time to first analgesic request after each scheduled dose will be noted for both Tramadol and Tapentadol group |