| CTRI Number |
CTRI/2023/11/059855 [Registered on: 15/11/2023] Trial Registered Prospectively |
| Last Modified On: |
06/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Post operative pain relief using Buprenorphine and Ketorolac |
|
Scientific Title of Study
|
A Randomized control study of post-operative analgesic effect of Buprenorphine and Ketorolac in elective abdomen surgeries under General Anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kameshwar |
| Designation |
Post Graduate |
| Affiliation |
Srimuthukumaran Medical College |
| Address |
Department of Anesthesiology, SriMuthukumaran Medical College Hospital and Research Center,Mangadu, Chennai
Chennai
TAMIL NADU
600069
India |
| Phone |
9176191069 |
| Fax |
|
| Email |
speak2kamesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramkumar |
| Designation |
Associate professor |
| Affiliation |
Srimuthukumaran Medical College |
| Address |
Department of Anesthesiology, SriMuthukumaran Medical College Hospital and Research Center,Mangadu, Chennai
Chennai
TAMIL NADU
600069
India |
| Phone |
9840744672 |
| Fax |
|
| Email |
ramkumar.pal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kameshwar |
| Designation |
Post Graduate |
| Affiliation |
Srimuthukumaran Medical College |
| Address |
Department of Anesthesiology,5thfloor, SriMuthukumaran Medical College Hospital and Research Center,Mangadu, Chennai
Chennai
TAMIL NADU
600069
India |
| Phone |
9176191069 |
| Fax |
|
| Email |
speak2kamesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Muthukumaran Medical College Hospital and Research Institute. |
|
|
Primary Sponsor
|
| Name |
Kameshwar ownself |
| Address |
Boys hostel, Sri Muthukumaran medical college, Mangadu, Chennai 600069 |
| 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 |
| Kameshwar |
Sri Muthukumaran Medical College Hospital and Research Institute |
Department of Anesthesiology, 5th floor,
Chennai
TAMIL NADU |
9176191069
speak2kamesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, (2) ICD-10 Condition: K400||Bilateral inguinal hernia, with obstruction, without gangrene, (3) ICD-10 Condition: K811||Chronic cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj. Buprenorphine |
4 micrograms/kg body weight intra muscular at the end of the surgery. One single dose |
| Intervention |
Inj. Ketorolac |
0.9mg/kg body weight intra muscular at the end of surgery. One single dose. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA I or II
2. Patients scheduled for elective abdomen surgeries under general anesthesia
3. Age: 20-60 years
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. Allergy or hypersensitivity to Buprenorphine and Ketorolac.
3. Pregnant and Lactating women
4. Patient having
a. Uncontrolled hypertension/diabetes mellitus.
b. Cardiac disease, Hepatic diseases, renal diseases.
c. History of chronic pain.
d. Psychiatric disease.
e. Alcohol or drug usage.
|
|
|
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 |
1. Dose of the study drug
2. Time duration needed for the usage of rescue analgesic
|
Baseline ( before the surgery),
Intra operative period,
Immediate post operative period-0 minutes
1 hour after post operative period,
2 hours after post operative period,
4 hours after post operative period,
6 hours after post operative period,
8 hours after post operative period,
12 hours after post operative period.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time duration for rescue analgesic |
At the end of surgery 0 hours,
1 hour after surgery,
2 hours after surgery,
4 hours after surgery,
6 hours after surgery,
8 hours after surgery,
12 hours after surgery. |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
01/12/2023 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pain is a major post-operative complication worldwide, which impairs normal body performance and
increases post-operative morbidity, hospitalization and susceptibility to infections which also can lead to
chronic pain development.To compare the analgesic
potential of Buprenorphine and Ketorolac for postoperative pain relief. |