| CTRI Number |
CTRI/2025/07/091166 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to evaluate the effect of giving Pre operative intramuscular injection diclofenac on post operative pain and use of opioids in patients posted for peri anal surgeries |
|
Scientific Title of Study
|
A Randomised Controlled Study to Evaluate the effect of preoperative
Intramuscular Diclofenae sodium on Duration of Postopreative Analgesia in Patients for Perianal
surgeries Under saddle Block at SMS Medical College, Jaipur . |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kanchan Chauhan |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College Attached Hospitals Jaipur Rajasthan |
| Address |
Department of anesthesia SMS Medical College Attached Hospitals Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
8107872222 |
| Fax |
|
| Email |
kanchan2371@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya agrawal |
| Designation |
Post graduate |
| Affiliation |
SMS Medical College Attached Hospitals Jaipur Rajasthan |
| Address |
Department of anesthesia SMS Medical College Attached Hospitals Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
8529493218 |
| Fax |
|
| Email |
Dadivyaagrawal02@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya agrawal |
| Designation |
Post graduate |
| Affiliation |
SMS Medical College Attached Hospitals Jaipur Rajasthan |
| Address |
Department of anesthesia SMS Medical College Attached Hospitals Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
8529493218 |
| Fax |
|
| Email |
Dadivyaagrawal02@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,2nd floor, Dhanvantari complex SMS Medical College and attached Hospital Jaipur Rajasthan 302004 |
|
|
Primary Sponsor
|
| Name |
SMS Medical College and Hospitals |
| Address |
Department of Anaesthesia, 2nd floor Dhanvantari complex SMS Medical College Jaipur Rajasthan 302004 |
| 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 |
| Divya agrawal |
SMS medical college |
DEPARTMENT OF ANAESTHESIA,OT2 (general surgery OT)
Jaipur
RAJASTHAN |
8529493218
dadivyaagrawal02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the ethics committee,SMS medical college and attached hospitals,jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9%Normal saline 2ml |
Intramuscular normal saline 0.9% 2ml injection post operative |
| Intervention |
Inj. Diclofenac sodium 1mg/kg |
Intramuscular Diclofenac sodium1mg/kg injection post operative |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients scheduled for elective perianal surgery under saddle block.
2.Patient willing to give informed written consent.
3.Age above 18 years, belonging to either sex.
4.American Society of Anaesthesiologist (ASA) physical status I and II. |
|
| ExclusionCriteria |
| Details |
1.Patient should not be a part of any other study
2.Patients who have contraindications for regional anaesthesia
3.Patients with bleeding disorders. 4.Allergic to amide local anaesthetics. 5.Duration of surgery more than 30 minutes. 6.Patients with mental health problems. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To assess and compare the difference in the time to first rescue analgesic request in the first 24 hours postoperatively between the two groups. 2. To assess and compare the difference in rescue analgesic consumption between the two groups. |
1. To assess and compare the difference in the time to first rescue analgesic request in the first 24 hours postoperatively between the two groups. 2. To assess and compare the difference in rescue analgesic consumption between the two groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
29/07/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Ambulatory anorectal surgery often utilizes standardised order sets and discharge instructions.Multimodal pain management,includes preemptive use of regional anaesthesia and postoperative use of NSAIDs & acetaminophen,has improved pain control and decreased opioid requirements in different types of surgery. |