| CTRI Number |
CTRI/2026/03/105475 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the effectiveness of a rectal suppository versus an injection for pain relief after surgery for fistula in ano |
|
Scientific Title of Study
|
comparing the efficacy and safety of rectal diclofenac versus intramuscular tramadol for postoperative pain management in adult patients undergoing fistula in ano surgery in a tertiary care centre : A randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhishek Reji |
| Designation |
Postgraduate |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
SRM Medical College Hospital and Research Centre, SRM Nagar,Potheri, Kattankulathur, Chengalpattu District
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9656770794 |
| Fax |
|
| Email |
abhishekreji@protonmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Reji |
| Designation |
Postgraduate |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
SRM Medical College Hospital and Research Centre, SRM Nagar,Potheri, Kattankulathur, Chengalpattu District
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9656770794 |
| Fax |
|
| Email |
abhishekreji@protonmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Reji |
| Designation |
Postgraduate |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
SRM Medical College Hospital and Research Centre, SRM Nagar,Potheri, Kattankulathur, Chengalpattu District
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9656770794 |
| Fax |
|
| Email |
abhishekreji@protonmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SRM Medical College Hospital and Research Centre |
| Address |
SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Abhishek Reji |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Department of General Surgery,SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur
Kancheepuram
TAMIL NADU |
9207539141
abhishekreji@protonmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj Tramadol |
INJ TRAMADOL 50 Mg is given every 8th hourly after Fistula in Ano surgery for 24 hours |
| Intervention |
Rectal diclofenac suppository |
One dose 100 mg of rectal diclofenac suppository Inserted after Fistula in Ano surgery within one hour of completion of procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age- 18–70 years
Sex-Both males and females
ASA status- ASA Physical Status I–II
Procedure- Elective perineal surgery for fistula-in-ano
Consent Willingness to participate and provide written informed consent
Evaluation- Completed preoperative clinical, laboratory, and anesthetic assessment
|
|
| ExclusionCriteria |
| Details |
Known allergy or hypersensitivity to diclofenac, NSAIDs, or tramadol
History of bronchial asthma
Bleeding disorders or abnormal coagulation profile
Hepatic or renal dysfunction
Pregnancy or lactation
Concomitant use of medications interacting with diclofenac (e.g., anticoagulants, nephrotoxic agents)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of postoperative pain scores (VAS) between Group A and Group B at 1, 6, 12, and 24 hours. |
Group A and Group B at 1, 6, 12, and 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of analgesia based on time to rescue analgesia
Frequency of rescue analgesia in 24 hours
Incidence of adverse effects
Hemodynamic stability in postoperative period
|
Over 24 hours |
|
|
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)
|
16/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/03/2026 |
| 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)
|
Completed |
| 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
|
Postoperative pain management is a critical factor in recovery following anorectal surgeries such as fistula in ano. While tramadol is a commonly used central analgesic in India, it often fails to target local inflammatory pain and is associated with significant side effects like nausea and vomiting. This prospective, randomized controlled trial was conducted at a tertiary care centre in Chennai to compare the efficacy of 100 mg rectal diclofenac suppositories against 50 mg intramuscular tramadol.
The study enrolled 60 adult patients (ASA I–II) who were randomized into two equal groups of 30. Both groups received standardized background analgesia with intravenous paracetamol. Pain intensity was measured using the visual analog scale (VAS) at 1, 6, 12, and 24 hours postoperatively. The results demonstrated that the diclofenac group had significantly lower pain scores at 6 and 12 hours compared to the tramadol group. Furthermore, the incidence of nausea was significantly lower in the diclofenac group (6.7 percent) compared to the tramadol group (33.3 percent). The study concludes that rectal diclofenac provides superior intermediate-phase analgesia and better tolerability, making it an effective opioid-sparing option for fistula surgery. |