Comparing the effect of diclofenac potassium and oral paracetamol on postoperative pain of elective inguinal hernia repair surgery

To determine the effects of oral diclofenac potassium and paracetamol on postoperative pain control following elective inguinal hernia repair surgery

A randomized, double-blind, active-controlled, parallel-group, phase 3 clinical trial on 34 patients. Randomization was performed using block randomization with variable block sizes (blocks of 4 and 6) generated by Random Allocation Software. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes (SNOSE).

In this double-blind trial at Imam Khomeini Hospital (Urmia), 34 hernia repair patients are randomized to receive identical capsules of diclofenac potassium (75 mg) or paracetamol (1 g) 60 min preoperatively. Pain is assessed via NRS at 6, 12, and 24 h; patients, assessors, and clinical staff are fully blinded.

Inclusion: Patients aged >18 years undergoing elective inguinal hernia repair at Imam Khomeini Hospital (2024).Exclusion: Drug allergy; analgesic use within 24 hours pre-surgery; history of GI bleeding; asthma; substance/alcohol abuse; comorbidities (anemia, DM, HTN, arthritis); renal impairment (creatinine >1.6 mg/dL); follow-up failure or major complications.

Patients are allocated into two groups: (1) Intervention group: receiving an oral dose of 75 mg diclofenac potassium 60 minutes preoperatively; and (2) Active control group: receiving an oral dose of 1 g paracetamol 60 minutes preoperatively. General anesthesia protocols and postoperative rescue analgesia are identical in both arms.

Postoperative pain intensity (static and dynamic) via NRS at 6, 12, and 24 h; Total rescue analgesic consumption within 24 h; Time to first analgesic request; Adverse drug reactions

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.

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.