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Published in: Journal of Gastrointestinal Surgery 2/2020

01-02-2020 | Hemorrhoidectomy | Original Article

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

Authors: Shahram Ala, Mina Alvandipour, Majid Saeedi, Mohaddeseh Mansourifar, Mahila Monajati, Afshin Shiva

Published in: Journal of Gastrointestinal Surgery | Issue 2/2020

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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.
Literature
1.
go back to reference Sneider E. B., Maykel J. A. Diagnosis and management of symptomatic hemorrhoids. Surgical Clinics of North America 2010: 90: 17–32.CrossRef Sneider E. B., Maykel J. A. Diagnosis and management of symptomatic hemorrhoids. Surgical Clinics of North America 2010: 90: 17–32.CrossRef
2.
go back to reference Figueiredo M. N., Campos F. G. Doppler-guided hemorrhoidal dearterialization/transanal hemorrhoidal dearterialization: technical evolution and outcomes after 20 years. World journal of gastrointestinal surgery 2016: 8: 232.CrossRef Figueiredo M. N., Campos F. G. Doppler-guided hemorrhoidal dearterialization/transanal hemorrhoidal dearterialization: technical evolution and outcomes after 20 years. World journal of gastrointestinal surgery 2016: 8: 232.CrossRef
3.
go back to reference Lohsiriwat V. Hemorrhoids: from basic pathophysiology to clinical management. World journal of gastroenterology: WJG 2012: 18: 2009.CrossRef Lohsiriwat V. Hemorrhoids: from basic pathophysiology to clinical management. World journal of gastroenterology: WJG 2012: 18: 2009.CrossRef
4.
go back to reference Lohsiriwat V. Treatment of hemorrhoids: a coloproctologist’s view. World Journal of Gastroenterology: WJG 2015: 21: 9245.CrossRef Lohsiriwat V. Treatment of hemorrhoids: a coloproctologist’s view. World Journal of Gastroenterology: WJG 2015: 21: 9245.CrossRef
5.
go back to reference Goligher J. C., Duthie H. L., Nixon H. H. Surgery of the anus, rectum and colon: Bailliere Tindall; 1980. Goligher J. C., Duthie H. L., Nixon H. H. Surgery of the anus, rectum and colon: Bailliere Tindall; 1980.
6.
go back to reference Shiau J.-M., Su H.-P., Chen H.-S., Hung K.-C., Lin S.-E., Tseng C.-C. Use of a topical anesthetic cream (EMLA) to reduce pain after hemorrhoidectomy. Regional anesthesia and pain medicine 2008: 33: 30–35.CrossRef Shiau J.-M., Su H.-P., Chen H.-S., Hung K.-C., Lin S.-E., Tseng C.-C. Use of a topical anesthetic cream (EMLA) to reduce pain after hemorrhoidectomy. Regional anesthesia and pain medicine 2008: 33: 30–35.CrossRef
7.
go back to reference Heng G., Tan K. Y. Excision hemorrhoidectomy: new methods to improve the outcomes of an old technique. Jentashapir Journal of Health Research 2016: 7. Heng G., Tan K. Y. Excision hemorrhoidectomy: new methods to improve the outcomes of an old technique. Jentashapir Journal of Health Research 2016: 7.
8.
go back to reference Huang Y.-J., Chen C.-Y., Chen R.-J., Kang Y.-N., Wei P.-L. Topical diltiazem ointment in post-hemorrhoidectomy pain relief: a meta-analysis of randomized controlled trials. Asian Journal of Surgery 2017. Huang Y.-J., Chen C.-Y., Chen R.-J., Kang Y.-N., Wei P.-L. Topical diltiazem ointment in post-hemorrhoidectomy pain relief: a meta-analysis of randomized controlled trials. Asian Journal of Surgery 2017.
9.
go back to reference Joshi G., Neugebauer E. Evidence-based management of pain after haemorrhoidectomy surgery. BJS 2010: 97: 1155–1168.CrossRef Joshi G., Neugebauer E. Evidence-based management of pain after haemorrhoidectomy surgery. BJS 2010: 97: 1155–1168.CrossRef
10.
go back to reference Poylin V., Quinn J., Messer K., Nagle D. Gabapentin significantly decreases posthemorrhoidectomy pain: a prospective study. International journal of colorectal disease 2014: 29: 1565–1569.CrossRef Poylin V., Quinn J., Messer K., Nagle D. Gabapentin significantly decreases posthemorrhoidectomy pain: a prospective study. International journal of colorectal disease 2014: 29: 1565–1569.CrossRef
11.
go back to reference Sugimoto T., Tsunoda A., Kano N., Kashiwagura Y., Hirose K.-i., Sasaki T. A randomized, prospective, double-blind, placebo-controlled trial of the effect of diltiazem gel on pain after hemorrhoidectomy. World journal of surgery 2013: 37: 2454–2457.CrossRef Sugimoto T., Tsunoda A., Kano N., Kashiwagura Y., Hirose K.-i., Sasaki T. A randomized, prospective, double-blind, placebo-controlled trial of the effect of diltiazem gel on pain after hemorrhoidectomy. World journal of surgery 2013: 37: 2454–2457.CrossRef
12.
go back to reference Perrotti P., Dominici P., Grossi E., Cerutti R., Antropoli C. Topical nifedipine with lidocaine ointment versus active control for pain after hemorrhoidectomy: results of a multicentre, prospective, randomized, double-blind study. Canadian Journal of Surgery 2010: 53: 17.PubMedCentral Perrotti P., Dominici P., Grossi E., Cerutti R., Antropoli C. Topical nifedipine with lidocaine ointment versus active control for pain after hemorrhoidectomy: results of a multicentre, prospective, randomized, double-blind study. Canadian Journal of Surgery 2010: 53: 17.PubMedCentral
13.
go back to reference Franceschilli L., D’Ugo S., de Luca E., Cadeddu F., Milito G., Di Lorenzo N. et al. Role of 0.4% glyceryl trinitrate ointment after haemorrhoidectomy: results of a prospective randomised study. International journal of colorectal disease 2013: 28: 365–369.CrossRef Franceschilli L., D’Ugo S., de Luca E., Cadeddu F., Milito G., Di Lorenzo N. et al. Role of 0.4% glyceryl trinitrate ointment after haemorrhoidectomy: results of a prospective randomised study. International journal of colorectal disease 2013: 28: 365–369.CrossRef
14.
go back to reference Patti R., Luigi A. P., Matteo A., Sergio S., Pietro R., Calogero F. Botulinum toxin vs. topical glyceryl trinitrate ointment for pain control in patients undergoing hemorrhoidectomy: a randomized trial. Diseases of the Colon & Rectum 2006: 49: 1741–1748.CrossRef Patti R., Luigi A. P., Matteo A., Sergio S., Pietro R., Calogero F. Botulinum toxin vs. topical glyceryl trinitrate ointment for pain control in patients undergoing hemorrhoidectomy: a randomized trial. Diseases of the Colon & Rectum 2006: 49: 1741–1748.CrossRef
15.
go back to reference Eshghi F., Hosseinimehr S. J., Rahmani N., Khademloo M., Norozi M. S., Hojati O. Effects of Aloe vera cream on posthemorrhoidectomy pain and wound healing: results of a randomized, blind, placebo-control study. The Journal of Alternative and Complementary Medicine 2010: 16: 647–650.CrossRef Eshghi F., Hosseinimehr S. J., Rahmani N., Khademloo M., Norozi M. S., Hojati O. Effects of Aloe vera cream on posthemorrhoidectomy pain and wound healing: results of a randomized, blind, placebo-control study. The Journal of Alternative and Complementary Medicine 2010: 16: 647–650.CrossRef
16.
go back to reference Ala S., Saeedi M., Eshghi F., Mirzabeygi P. Topical metronidazole can reduce pain after surgery and pain on defecation in postoperative hemorrhoidectomy. Diseases of the Colon & Rectum 2008: 51: 235–238.CrossRef Ala S., Saeedi M., Eshghi F., Mirzabeygi P. Topical metronidazole can reduce pain after surgery and pain on defecation in postoperative hemorrhoidectomy. Diseases of the Colon & Rectum 2008: 51: 235–238.CrossRef
17.
go back to reference Ala S., Eshghi F., Enayatifard R., Fazel P., Rezaei B., Hadianamrei R. Efficacy of cholestyramine ointment in reduction of postoperative pain and pain during defecation after open hemorrhoidectomy: results of a prospective, single-center, randomized, double-blind, placebo-controlled trial. World journal of surgery 2013: 37: 657–662.CrossRef Ala S., Eshghi F., Enayatifard R., Fazel P., Rezaei B., Hadianamrei R. Efficacy of cholestyramine ointment in reduction of postoperative pain and pain during defecation after open hemorrhoidectomy: results of a prospective, single-center, randomized, double-blind, placebo-controlled trial. World journal of surgery 2013: 37: 657–662.CrossRef
18.
go back to reference Alvandipour M., Ala S., Tavakoli H., Charati J. Y., Shiva A. Efficacy of 10% sucralfate ointment after anal fistulotomy: a prospective, double-blind, randomized, placebo-controlled trial. International Journal of Surgery 2016: 36: 13–17.CrossRef Alvandipour M., Ala S., Tavakoli H., Charati J. Y., Shiva A. Efficacy of 10% sucralfate ointment after anal fistulotomy: a prospective, double-blind, randomized, placebo-controlled trial. International Journal of Surgery 2016: 36: 13–17.CrossRef
19.
go back to reference Ala S., Saeedi M., Eshghi F., Rafati M., Hejazi V., Hadianamrei R. Efficacy of 10% sucralfate ointment in the reduction of acute postoperative pain after open hemorrhoidectomy: a prospective, double-blind, randomized, placebo-controlled trial. World journal of surgery 2013: 37: 233–238.CrossRef Ala S., Saeedi M., Eshghi F., Rafati M., Hejazi V., Hadianamrei R. Efficacy of 10% sucralfate ointment in the reduction of acute postoperative pain after open hemorrhoidectomy: a prospective, double-blind, randomized, placebo-controlled trial. World journal of surgery 2013: 37: 233–238.CrossRef
20.
go back to reference Ala S., Alvandipour M., Saeedi M., Hamidian M., Shiva A., Rahmani N. et al. Effects of topical atorvastatin (2%) on posthemorrhoidectomy pain and wound healing: a randomized double-blind placebo-controlled clinical trial. World journal of surgery 2017: 41: 596–602.CrossRef Ala S., Alvandipour M., Saeedi M., Hamidian M., Shiva A., Rahmani N. et al. Effects of topical atorvastatin (2%) on posthemorrhoidectomy pain and wound healing: a randomized double-blind placebo-controlled clinical trial. World journal of surgery 2017: 41: 596–602.CrossRef
21.
go back to reference Whitehead R., Puil E., Ries C., Schwarz S., Wall R., Cooke J. et al. GABA B receptor-mediated selective peripheral analgesia by the non-proteinogenic amino acid, isovaline. Neuroscience 2012: 213: 154–160.CrossRef Whitehead R., Puil E., Ries C., Schwarz S., Wall R., Cooke J. et al. GABA B receptor-mediated selective peripheral analgesia by the non-proteinogenic amino acid, isovaline. Neuroscience 2012: 213: 154–160.CrossRef
22.
go back to reference Bowery N. G. Baclofen: therapeutic use and potential of the prototypic GABA B receptor agonist. GABAB Receptor: Springer; 2016, p. 337–356.CrossRef Bowery N. G. Baclofen: therapeutic use and potential of the prototypic GABA B receptor agonist. GABAB Receptor: Springer; 2016, p. 337–356.CrossRef
23.
go back to reference Nyirjesy P., Lev-Sagie A., Mathew L., Culhane J. F. Topical amitriptyline-baclofen cream for the treatment of provoked vestibulodynia. Journal of Lower Genital Tract Disease 2009: 13: 230–236.CrossRef Nyirjesy P., Lev-Sagie A., Mathew L., Culhane J. F. Topical amitriptyline-baclofen cream for the treatment of provoked vestibulodynia. Journal of Lower Genital Tract Disease 2009: 13: 230–236.CrossRef
24.
go back to reference Hesselink J. M. K., Kopsky D. J., Sajben N. L. Vulvodynia and proctodynia treated with topical baclofen 5% and palmitoylethanolamide. Archives of gynecology and obstetrics 2014: 290: 389–393.CrossRef Hesselink J. M. K., Kopsky D. J., Sajben N. L. Vulvodynia and proctodynia treated with topical baclofen 5% and palmitoylethanolamide. Archives of gynecology and obstetrics 2014: 290: 389–393.CrossRef
25.
go back to reference Barton D. L., Wos E. J., Qin R., Mattar B. I., Green N. B., Lanier K. S. et al. A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy: NCCTG trial N06CA. Supportive Care in Cancer 2011: 19: 833–841.CrossRef Barton D. L., Wos E. J., Qin R., Mattar B. I., Green N. B., Lanier K. S. et al. A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy: NCCTG trial N06CA. Supportive Care in Cancer 2011: 19: 833–841.CrossRef
26.
go back to reference Kopsky D. J., Hesselink J. M. K. Neuropathic pain as a result of acromegaly, treated with topical baclofen cream. Journal of pain and symptom management 2013: 46: e4-e5.CrossRef Kopsky D. J., Hesselink J. M. K. Neuropathic pain as a result of acromegaly, treated with topical baclofen cream. Journal of pain and symptom management 2013: 46: e4-e5.CrossRef
27.
go back to reference Tian J., Lu Y., Zhang H., Chau C. H., Dang H. N., Kaufman D. L. γ-Aminobutyric acid inhibits T cell autoimmunity and the development of inflammatory responses in a mouse type 1 diabetes model. The Journal of Immunology 2004: 173: 5298–5304.CrossRef Tian J., Lu Y., Zhang H., Chau C. H., Dang H. N., Kaufman D. L. γ-Aminobutyric acid inhibits T cell autoimmunity and the development of inflammatory responses in a mouse type 1 diabetes model. The Journal of Immunology 2004: 173: 5298–5304.CrossRef
28.
go back to reference Duthey B., Hübner A., Diehl S., Boehncke S., Pfeffer J., Boehncke W. H. Anti-inflammatory effects of the GABAB receptor agonist baclofen in allergic contact dermatitis. Experimental dermatology 2010: 19: 661–666.CrossRef Duthey B., Hübner A., Diehl S., Boehncke S., Pfeffer J., Boehncke W. H. Anti-inflammatory effects of the GABAB receptor agonist baclofen in allergic contact dermatitis. Experimental dermatology 2010: 19: 661–666.CrossRef
29.
go back to reference Milligan E., Morgan C. N., Jones L., Officer R. Surgical anatomy of the anal canal, and the operative treatment of haemorrhoids. The Lancet 1937: 230: 1119–1124.CrossRef Milligan E., Morgan C. N., Jones L., Officer R. Surgical anatomy of the anal canal, and the operative treatment of haemorrhoids. The Lancet 1937: 230: 1119–1124.CrossRef
30.
go back to reference Satzinger U., Feil W., Glaser K. Recto anal repair (RAR): a viable new treatment option for high-grade hemorrhoids. One year results of a prospective study. Pelviperineology 2009: 28: 37–42. Satzinger U., Feil W., Glaser K. Recto anal repair (RAR): a viable new treatment option for high-grade hemorrhoids. One year results of a prospective study. Pelviperineology 2009: 28: 37–42.
31.
go back to reference Sayfan J. Complications of Milligan-Morgan hemorrhoidectomy. Digestive surgery 2001: 18: 131–133.CrossRef Sayfan J. Complications of Milligan-Morgan hemorrhoidectomy. Digestive surgery 2001: 18: 131–133.CrossRef
32.
go back to reference Kirchhoff P., Clavien P.-A., Hahnloser D. Complications in colorectal surgery: risk factors and preventive strategies. Patient safety in surgery 2010: 4: 5.CrossRef Kirchhoff P., Clavien P.-A., Hahnloser D. Complications in colorectal surgery: risk factors and preventive strategies. Patient safety in surgery 2010: 4: 5.CrossRef
33.
go back to reference Ravo B., Amato A., Bianco V., Boccasanta P., Bottini C., Carriero A. et al. Complications after stapled hemorrhoidectomy: can they be prevented? Techniques in coloproctology 2002: 6: 83–88.CrossRef Ravo B., Amato A., Bianco V., Boccasanta P., Bottini C., Carriero A. et al. Complications after stapled hemorrhoidectomy: can they be prevented? Techniques in coloproctology 2002: 6: 83–88.CrossRef
34.
go back to reference Uzzaman M. M., Siddiqui M. R. S. A brief literature review on the management of post-haemorrhoidectomy pain. Surgical Techniques Development 2011: 1: 32.CrossRef Uzzaman M. M., Siddiqui M. R. S. A brief literature review on the management of post-haemorrhoidectomy pain. Surgical Techniques Development 2011: 1: 32.CrossRef
35.
go back to reference Oderda G. Challenges in the management of acute postsurgical pain. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy 2012: 32. Oderda G. Challenges in the management of acute postsurgical pain. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy 2012: 32.
36.
go back to reference Kopsky D. J., Keppel Hesselink J. M., Casale R. Walking with neuropathic pain: paradoxical shift from burden to support? Case reports in medicine 2015: 2015. Kopsky D. J., Keppel Hesselink J. M., Casale R. Walking with neuropathic pain: paradoxical shift from burden to support? Case reports in medicine 2015: 2015.
37.
go back to reference Ataka T., Kumamoto E., Shimoji K., Yoshimura M. Baclofen inhibits more effectively C-afferent than Aδ-afferent glutamatergic transmission in substantia gelatinosa neurons of adult rat spinal cord slices. Pain 2000: 86: 273–282.CrossRef Ataka T., Kumamoto E., Shimoji K., Yoshimura M. Baclofen inhibits more effectively C-afferent than Aδ-afferent glutamatergic transmission in substantia gelatinosa neurons of adult rat spinal cord slices. Pain 2000: 86: 273–282.CrossRef
38.
go back to reference Casale R., Symeonidou Z., Bartolo M. Topical treatments for localized neuropathic pain. Current pain and headache reports 2017: 21: 15.CrossRef Casale R., Symeonidou Z., Bartolo M. Topical treatments for localized neuropathic pain. Current pain and headache reports 2017: 21: 15.CrossRef
Metadata
Title
Effect of Topical Baclofen 5% on Post-Hemorrhoidectomy Pain: Randomized Double Blind Placebo-Controlled Clinical Trial
Authors
Shahram Ala
Mina Alvandipour
Majid Saeedi
Mohaddeseh Mansourifar
Mahila Monajati
Afshin Shiva
Publication date
01-02-2020
Publisher
Springer US
Published in
Journal of Gastrointestinal Surgery / Issue 2/2020
Print ISSN: 1091-255X
Electronic ISSN: 1873-4626
DOI
https://doi.org/10.1007/s11605-019-04147-7

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