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

  • Original Article
  • Published:
Journal of Gastrointestinal Surgery

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.

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Funding

This work was supported by a grant from Mazandaran University of Medical Sciences.

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Authors and Affiliations

Authors

Contributions

Study design: Shahram Ala, Mina Alvandipour

Implementation: Mina Alvandipour, Majid Saeedi, Mohaddeseh Mansourifar

Data acquisition: Mina Alvandipour, Mohaddeseh Mansourifar, Mahila Monajati

Drafting of manuscript: Shahram Ala, Afshin Shiva

Critical revision of manuscript: Shahram Ala, Afshin Shiva

Corresponding author

Correspondence to Mina Alvandipour.

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Ala, S., Alvandipour, M., Saeedi, M. et al. Effect of Topical Baclofen 5% on Post-Hemorrhoidectomy Pain: Randomized Double Blind Placebo-Controlled Clinical Trial. J Gastrointest Surg 24, 405–410 (2020). https://doi.org/10.1007/s11605-019-04147-7

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  • DOI: https://doi.org/10.1007/s11605-019-04147-7

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