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IRCT20221126056613N9 IRCT 2026-08-20 Oroumia University of Medical Sciences Comparison of the analgesic effects of diclofenac and paracetamol on post-hernia surgery pain Comparing the effect of diclofenac potassium and oral paracetamol on postoperative pain of elective inguinal hernia repair surgery 2026-09-23 anticipated 34 Recruiting https://irct.ir/trial/92624 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Specific methodological features of this trial include the strict standardization of the general anesthesia protocol across all study groups, without the use of regional nerve blocks or neuraxial anesthesia, to eliminate confounding effects on postoperative pain. Additionally, postoperative pain intensity is evaluated both at rest (static NRS) and during voluntary coughing (dynamic NRS) to ensure a comprehensive assessment of analgesic efficacy during physical movement. Furthermore, the Numerical Rating Scale (NRS) was selected over the Visual Analogue Scale (VAS) due to its documented higher compliance rates, superior responsiveness, and ease of use in a mixed-age adult population, Randomization description: In this randomized, double-blind clinical trial, eligible patients scheduled for elective inguinal hernia repair are allocated to either the oral diclofenac potassium (75 mg) or oral paracetamol (1 g) group using block randomization with permuted blocks of varying sizes. The random allocation sequence is generated using computer-generated random numbers by an independent biostatistician not involved in clinical care. To ensure allocation concealment, sequentially numbered, opaque, sealed envelopes (SNOSE) are used. Each envelope is opened only on the morning of surgery (60 minutes preoperatively) by a designated nurse after baseline evaluations and written informed consent are completed. Both the patients and the outcome assessors remain fully blinded to group assignments throughout the intervention and follow-up periods, Blinding description: This study is designed and conducted as a double-blind randomized clinical trial. Patients and outcome assessors (who evaluate NRS pain scores, total analgesic consumption, and adverse effects) are blinded to the assigned treatment groups (oral diclofenac potassium vs. oral paracetamol); study medications are coded and prepared in identical, sequentially numbered, opaque packages by an independent researcher not involved in clinical care. Furthermore, healthcare staff administering routine care and rescue analgesia are unaware of group allocations, and randomization codes will remain concealed until data collection and statistical analyses are fully completed. 3 Inguinal Hernia. Intervention 1: Intervention group: Diclofenac Potassium Group Patients in this group receive a single oral dose of 75 mg diclofenac potassium in an opaque capsule with 30 mL of water, administered 60 minutes prior to surgery (preemptively). Capsules are identical in shape, size, color, weight, and packaging to the active control group. Intervention 2: Intervention group: Active Control Group (Paracetamol)Patients in this group receive a single oral dose of 1 g (1000 mg) paracetamol in an opaque capsule with 30 mL of water, administered 60 minutes prior to surgery (preemptively). Capsules are identical in appearance, size, color, weight, and coding to the intervention group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is A decision regarding publication will be made after completion of the study and based on the results obtained.
public Dr. Ali Akbar Nasiri
Emam Khomini university hospital, Ershad Ave., Modarres Blvd.
Urmia Iran (Islamic Republic of) 5715789397 +98 44 3346 9931 nasiriali7@gmail.com Oroumia University of Medical Sciences scientific Dr. Ali Akbar Nasiri
Emam Khomini university hospital, Ershad Ave., Modarres Blvd.
Urmia Iran (Islamic Republic of) 5715789397 +98 44 3346 9931 Nasiriali7@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Adult patients (≥18 years) Patients undergoing elective inguinal surgery 18 years no limit Both Concomitant medical or psychiatric conditions that could prevent completion of follow‑up. History of upper gastrointestinal bleeding related to prior treatment with NSAIDs. Underlying comorbidities (anemia, DM, HTN, arthritis) Moderate or severe renal patients" and "Creatinine > 1.6" Known asthmatic patients. History of alcohol consumption, opioid use, or use of other illicit drugs. Use of NSAIDs or paracetamol within 24 hours before surgery. Participants with known allergy to the study drugs. (Any) intervention required in the event of complications. K40 Inguinal hernia Treatment - Drugs Treatment - Drugs Intervention group: Diclofenac Potassium Group Patients in this group receive a single oral dose of 75 mg diclofenac potassium in an opaque capsule with 30 mL of water, administered 60 minutes prior to surgery (preemptively). Capsules are identical in shape, size, color, weight, and packaging to the active control group. Intervention group: Active Control Group (Paracetamol)Patients in this group receive a single oral dose of 1 g (1000 mg) paracetamol in an opaque capsule with 30 mL of water, administered 60 minutes prior to surgery (preemptively). Capsules are identical in appearance, size, color, weight, and coding to the intervention group. Postoperative Acute Pain Intensity. Timepoint: at 6, 12, and 24 hours postoperatively. Method of measurement: using the Numeric Rating Scale (NRS) on an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Oroumia University of Medical Sciences Approved 2025-07-30 Ethics Committee in Research of Imam Khomeini Medical Education Center of Urmia University of Medica Emam Khomeini University Hospital, Ershad Ave., Modarres Blvd. Urmia West Azarbaijan Iran (Islamic Republic of)