Effect of Topical Baclofen 5% on Post-Hemorrhoidectomy Pain: Randomized Double Blind Placebo-Controlled Clinical Trial.

Abstract

BACKGROUND:

Baclofen is an agonist for a subtype of gamma-amino butyric acid (GABA-B) receptors and traditionally been used for the systemic treatment of spasticity. Topical application of baclofen has been shown to reduce pain in patients with localized neuropathic pain.

OBJECTIVES:

In this study, we investigate the efficacy of baclofen cream (5%) in reducing postoperative pain and analgesic requirement after open hemorrhoidectomy.

DESIGN:

The patients were randomly assigned to either baclofen (5%) cream or placebo immediately after surgery and then every 12 h for 14 days.

PATIENTS:

A total of 66 patients with third- and fourth-degree hemorrhoids undergoing open hemorrhoidectomy were randomly assigned to this trial.

SETTING:

This study was conducted at a single educational hospital.

PRIMARY AND SECONDARY OUTCOME MEASURES:

The primary outcomes were intensity of pain, measured with a visual analog scale, and the analgesic requirement, measured by the amount of the acetaminophen consumption.

RESULTS:

No significant difference was found in baseline characteristics between the two groups. Postoperative pain score of the baclofen group was significantly lower on week 1 (P = 0.01) and week 2 (P = 0.02) than the placebo group. Similarly, patients in the baclofen group consumed significantly less analgesic medication on week 1 (P = 0.025) and week 2 (P = 0.024) than the control group.

CONCLUSION:

Topical application of baclofen effectively relieves pain after hemorrhoidectomy with minimal side effects.

• Authors: Shahram Ala, Mina Alvandipour, Majid Saeedi, Mohaddeseh Mansourifar, Mahila Monajati, Afshin Shiva
• Journal: Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract (J Gastrointest Surg) Vol. 24 Issue 2 Pg. 405-410 (02 2020) ISSN: 1873-4626 [Electronic] United States
• PMID: 30783957 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics
• GABA-B Receptor Agonists
• Acetaminophen
• Baclofen

Topics

• Acetaminophen (therapeutic use)
• Administration, Topical
• Adult
• Analgesics (therapeutic use)
• Baclofen (administration & dosage, therapeutic use)
• Double-Blind Method
• Female
• GABA-B Receptor Agonists (administration & dosage, therapeutic use)
• Hemorrhoidectomy (adverse effects)
• Hemorrhoids (surgery)
• Humans
• Male
• Middle Aged
• Pain Measurement
• Pain, Postoperative (drug therapy, etiology)
• Prospective Studies