| CTRI Number |
CTRI/2020/07/026914 [Registered on: 30/07/2020] Trial Registered Prospectively |
| Last Modified On: |
03/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to find the effectiveness of two drugs, Diclofenac and Buprenorphine to help relieve pain in patients who develop acute inflammation of the pancreas, namely pancreatitis |
|
Scientific Title of Study
|
Comparative effects of intravenous Diclofenac and Buprenorphine for pain relief in patients with Acute Pancreatitis : A Randomized Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mayank Saini |
| Designation |
Junior Resident |
| Affiliation |
PGIMER,Chandigarh |
| Address |
Department of Gastroenterology,
Post Graduate Institute of Medical Education and Research, Chandigarh
Sector - 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09419201587 |
| Fax |
|
| Email |
mayanksaini870@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayanta Samanta |
| Designation |
Assistant Professor, Department of Gastroenterology, PGIMER |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Gastroenterology
PGIMER
Sector - 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855319529 |
| Fax |
|
| Email |
dj_samanta@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Jayanta Samanta |
| Designation |
Assistant Professor, Department of Gastroenterology, PGIMER |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Gastroenterology
PGIMER
Sector - 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855319529 |
| Fax |
|
| Email |
dj_samanta@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Gastroenterology,
PGIMER, Chandigarh
Sector-12
Chandigarh - 160012 |
|
|
Primary Sponsor
|
| Name |
Mayank Saini |
| Address |
418,Sector 15-A,Chandigarh |
| Type of Sponsor |
Other [Primary Investigator] |
|
|
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 |
| Jayanta Samanta |
PGIMER, Chandigarh |
Faculty Office, Department of Gastroenterology, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH |
9855319529
dj_samanta@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Postgraduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K859||Acute pancreatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buprenorphine |
Buprenorphine 0.3 mg intravenous 8 hourly for 40 hours |
| Comparator Agent |
Diclofenac |
Diclofenac 75 mg Intravenous 8 hourly for 40 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Acute pancreatitis as defined by the clinical symptoms, elevation in serum amylase level(more than three times the upper limit of normal range) or imaging finding
Abdominal pain at the time of enrolment
Patients who have presented to the hospital within the first 5 days after onset of pain.
|
|
| ExclusionCriteria |
| Details |
Pregnancy
Patients of acute pancreatitis who have renal failure (Serum Creatinine > 1.5 mg/dl) at presentation
Patients who were contraindicated to Opioids and NSAIDS
Who already take Opioids and NSAIDS for other reasons
Patients with history of coronary artery disease
Patients with altered mental status
Patients with imaging evidence of chronic pancreatitis
Patients requiring ventilatory support
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Difference in the dose of fentanyl required in diclofenac and buprenorphine group
2. Difference in the number of effective and ineffective demands in diclofenac and buprenorphine group
|
24 hours, 48 hours, 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Difference in the pain free interval in diclofenac and buprenorphine group |
24, 48 and 72 hours
|
| Difference in the mean VAS score in the diclofenac and buprenorphine group |
24, 48 and 72 hours |
| The difference in the adverse events between the 2 groups |
72 hours |
| The development of organ failure, assessed using the Marshall scoring |
72 hours |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="9" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a Randomized, double blind, parallel group, single centre trial, comparing the efficacy of diclofenac,(75 mg 8 hourly) and buprenorphine(0.3 mg 8 hourly), both given for 40 hours, in 48 patients of Acute Pancreatitis, who present to PGIMER Chandigarh. Fentanyl via a patient controlled analgesia(PCA) pump will be given in both group of patients and objective methods will be utilised to assess pain relief.The primary outcome measures will be the difference in the dose of fentany required and the difference in the number of effective and ineffective demands in the diclofenac and buprenorphine group,measured at 24, 48 and 72 hours. The secondary outcomes will be the difference in the pain free interval , mean VAS scores and adverse events in the diclofenac and buprenorphine groups as well as the development of organ failure, assessed using Marshall scoring, during the 72 hours time period. |