Background: Postoperative pain remains the greatest problem after hemorrhoidectomy. Pain is hypothesized to arise from bacterial infection, sphincter spasm, and local inflammation.
Objective: This trial was conducted to assess the effects of metronidazole, diltiazem, and lidocaine on posthemorrhoidectomy pain.
Design: A double-blinded randomized controlled factorial trial.
Settings: This multicenter trial was conducted in Auckland, New Zealand.
Patients: A total of 192 participants were randomly assigned (1:1:1:1) into 4 parallel arms.
Interventions: Participants were randomly assigned into 1 of 4 groups receiving topical treatment with 10% metronidazole, 10% metronidazole + 2% diltiazem, 10% metronidazole + 4% lidocaine, or 10% metronidazole + 2% diltiazem + 4% lidocaine. Participants were instructed to apply treatment to the anal verge 3 times daily for 7 days.
Main outcome measures: The primary outcome was pain on the visual analog scale on day 4. The secondary outcomes included analgesia usage, pain during bowel movement, and functional recovery index.
Results: There was no significant difference in the pain and recovery scores when diltiazem or lidocaine was added to metronidazole (score difference between presence and absence of diltiazem in the formulation: -3.69; 95% CI, -13.3 to 5.94; p = 0.46; between presence and absence of lidocaine: -5.67; 95% CI, -15.5 to 3.80; p = 0.24). The combination of metronidazole + diltiazem + lidocaine did not further reduce pain. Secondary analysis revealed a significant difference between the best (metronidazole + lidocaine) and worst (metronidazole + diltiazem + lidocaine) groups in both pain and functional recovery scores. There were no significant differences in analgesic usage, complications, or return to work between the groups. No clinically important adverse events were reported. The adverse event rate did not change in the intervention groups.
Limitations: Topical metronidazole was used in the control group rather than a pure placebo.
Conclusions: There was no significant difference in pain when topical diltiazem, lidocaine, or both were added to topical metronidazole. See Video Abstract .
Clinicaltrialsgov identifier: NCT04276298.
Ensayo controlado aleatorizado de analgesia tpica posterior a hemorroidectoma ensayo taph: ANTECEDENTES:El dolor postoperatorio sigue siendo el mayor problema tras hemorroidectomía. La hipótesis es que el dolor se debe a infección bacteriana, el espasmo esfínteriano e inflamación local.OBJETIVO:Se realizó un ensayo factorial aleatorizado y controlado para evaluar los efectos del metronidazol, el diltiazem y la lidocaína en el dolor posthemorroidectomía.DISEÑO:Ensayo factorial controlado aleatorizado do