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A study to compare the effectiveness of a rectal suppository versus an injection for pain relief after surgery for fistula in ano

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/105475
Enrollment
60
Registered
2026-03-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: 8- Other Procedures

Interventions

Intervention1: Rectal diclofenac suppository: One dose 100 mg of rectal diclofenac suppository Inserted after Fistula in Ano surgery within one hour of completion of procedure Control Intervention1: I

Sponsors

SRM Medical College Hospital and Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
Comparison of postoperative pain scores (VAS) between Group A and Group B at 1, 6, 12, and 24 hours.Timepoint: Group A and Group B at 1, 6, 12, and 24 hours.—

Secondary

MeasureTime frame
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 Timepoint: Over 24 hours—

Countries

India

Contacts

Public ContactDr Abhishek Reji

SRM Medical College Hospital and Research Centre

abhishekreji@protonmail.com9656770794

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026