Topical glyceryl trinitrate ointment for pain related to anal hypertonia after stapled hemorrhoidopexy: A randomized controlled trial

Francesco Saverio Mari, Giuseppe Nigri, Anna Dall'Oglio, Umile Michele Cosenza, Andrea Milillo, Irene Terrenato, Alessandra Pancaldi, Antonio Brescia

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

BACKGROUND: Postoperative pain after stapled hemorrhoidopexy is cause for considerable concern and may be related to contracture of continence muscles. OBJECTIVE: We compared glyceryl trinitrate 0.4% ointment with lidocaine chlorohydrate 2.5% gel as topical therapy to relieve the pain of anorectal muscular spasm after stapled hemorrhoidopexy. DESIGN: This was a single-blind, parallel-group, randomized controlled trial. SETTING: The study was conducted at a university teaching hospital in Rome, Italy. PATIENTS: Patients with severe postoperative anal pain after stapled hemorrhoidopexy, clinical evidence of anal hypertonia, and elevated anal resting pressure on manometric assessment were enrolled. Patients treated for concomitant anorectal disease were excluded. INTERVENTIONS: Participants were randomly assigned to receive twice-daily, local topical application of glyceryl trinitrate or lidocaine for a total of 14 days. MAIN OUTCOME MEASURES: Pain intensity was measured on a visual analog scale at baseline and after 2, 7, and 14 days of therapy. Anal resting pressure was measured preand postoperatively and after 14 days of therapy. RESULTS: Of 480 patients undergoing stapled hemorrhoidopexy, 121 had severe postoperative pain (score >3) and underwent clinical examination; 45 patients (13 women, 28 men) had clinically evident anal hypertonia and underwent anorectal manometry; 41 patients had elevated anal resting pressure and entered the study. Mean pain scores were significantly lower with glyceryl trinitrate than with lidocaine on day 2 (2.5 ± 1.0 vs 4.0 ± 1.1, p <0.0001); day 7 (1.4 vs 2.8, p <0.0001); and day 14 (0.4 vs 1.4, p = 0.003). Anal resting pressure was significantly lower with glyceryl trinitrate than with lidocaine on day 14 (75.4 ± 7.4 mmHg vs 85.6 ± 7.9 mmHg, p <0.0001). LIMITATIONS: GTN-induced reduction in sphincter tone could not be evaluated during the initial period, when pain was most intense. Because anorectal manometry was performed only in patients with severe pain and clinical evidence of anal hypertonia, firm conclusions cannot be drawn as to frequency of hypertonia after SH. Bias may have been introduced because the surgical team could not be blinded. CONCLUSION: Topical 0.4% glyceryl trinitrate is effective in relieving pain and reducing anal resting pressure in patients with anal hypertonia after stapled hemorrhoidopexy.

Original languageEnglish
Pages (from-to)768-773
Number of pages6
JournalDiseases of the Colon and Rectum
Volume56
Issue number6
DOIs
Publication statusPublished - Jun 2013

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Nitroglycerin
Ointments
Randomized Controlled Trials
Pain
Lidocaine
Pressure
Postoperative Pain
Manometry
Rectal Diseases
Spasm
Contracture
Visual Analog Scale
Teaching Hospitals
Italy
Therapeutics
Gels
Muscles

Keywords

  • Anal hypertonia
  • Anal manometry
  • Glyceryl trinitrate 0.4% ointment
  • Pain
  • Stapled anopexy
  • Stapled hemorrhoidopexy

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Topical glyceryl trinitrate ointment for pain related to anal hypertonia after stapled hemorrhoidopexy : A randomized controlled trial. / Mari, Francesco Saverio; Nigri, Giuseppe; Dall'Oglio, Anna; Cosenza, Umile Michele; Milillo, Andrea; Terrenato, Irene; Pancaldi, Alessandra; Brescia, Antonio.

In: Diseases of the Colon and Rectum, Vol. 56, No. 6, 06.2013, p. 768-773.

Research output: Contribution to journalArticle

Mari, FS, Nigri, G, Dall'Oglio, A, Cosenza, UM, Milillo, A, Terrenato, I, Pancaldi, A & Brescia, A 2013, 'Topical glyceryl trinitrate ointment for pain related to anal hypertonia after stapled hemorrhoidopexy: A randomized controlled trial', Diseases of the Colon and Rectum, vol. 56, no. 6, pp. 768-773. https://doi.org/10.1097/DCR.0b013e31828b282c
Mari, Francesco Saverio ; Nigri, Giuseppe ; Dall'Oglio, Anna ; Cosenza, Umile Michele ; Milillo, Andrea ; Terrenato, Irene ; Pancaldi, Alessandra ; Brescia, Antonio. / Topical glyceryl trinitrate ointment for pain related to anal hypertonia after stapled hemorrhoidopexy : A randomized controlled trial. In: Diseases of the Colon and Rectum. 2013 ; Vol. 56, No. 6. pp. 768-773.
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abstract = "BACKGROUND: Postoperative pain after stapled hemorrhoidopexy is cause for considerable concern and may be related to contracture of continence muscles. OBJECTIVE: We compared glyceryl trinitrate 0.4{\%} ointment with lidocaine chlorohydrate 2.5{\%} gel as topical therapy to relieve the pain of anorectal muscular spasm after stapled hemorrhoidopexy. DESIGN: This was a single-blind, parallel-group, randomized controlled trial. SETTING: The study was conducted at a university teaching hospital in Rome, Italy. PATIENTS: Patients with severe postoperative anal pain after stapled hemorrhoidopexy, clinical evidence of anal hypertonia, and elevated anal resting pressure on manometric assessment were enrolled. Patients treated for concomitant anorectal disease were excluded. INTERVENTIONS: Participants were randomly assigned to receive twice-daily, local topical application of glyceryl trinitrate or lidocaine for a total of 14 days. MAIN OUTCOME MEASURES: Pain intensity was measured on a visual analog scale at baseline and after 2, 7, and 14 days of therapy. Anal resting pressure was measured preand postoperatively and after 14 days of therapy. RESULTS: Of 480 patients undergoing stapled hemorrhoidopexy, 121 had severe postoperative pain (score >3) and underwent clinical examination; 45 patients (13 women, 28 men) had clinically evident anal hypertonia and underwent anorectal manometry; 41 patients had elevated anal resting pressure and entered the study. Mean pain scores were significantly lower with glyceryl trinitrate than with lidocaine on day 2 (2.5 ± 1.0 vs 4.0 ± 1.1, p <0.0001); day 7 (1.4 vs 2.8, p <0.0001); and day 14 (0.4 vs 1.4, p = 0.003). Anal resting pressure was significantly lower with glyceryl trinitrate than with lidocaine on day 14 (75.4 ± 7.4 mmHg vs 85.6 ± 7.9 mmHg, p <0.0001). LIMITATIONS: GTN-induced reduction in sphincter tone could not be evaluated during the initial period, when pain was most intense. Because anorectal manometry was performed only in patients with severe pain and clinical evidence of anal hypertonia, firm conclusions cannot be drawn as to frequency of hypertonia after SH. Bias may have been introduced because the surgical team could not be blinded. CONCLUSION: Topical 0.4{\%} glyceryl trinitrate is effective in relieving pain and reducing anal resting pressure in patients with anal hypertonia after stapled hemorrhoidopexy.",
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AU - Mari, Francesco Saverio

AU - Nigri, Giuseppe

AU - Dall'Oglio, Anna

AU - Cosenza, Umile Michele

AU - Milillo, Andrea

AU - Terrenato, Irene

AU - Pancaldi, Alessandra

AU - Brescia, Antonio

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N2 - BACKGROUND: Postoperative pain after stapled hemorrhoidopexy is cause for considerable concern and may be related to contracture of continence muscles. OBJECTIVE: We compared glyceryl trinitrate 0.4% ointment with lidocaine chlorohydrate 2.5% gel as topical therapy to relieve the pain of anorectal muscular spasm after stapled hemorrhoidopexy. DESIGN: This was a single-blind, parallel-group, randomized controlled trial. SETTING: The study was conducted at a university teaching hospital in Rome, Italy. PATIENTS: Patients with severe postoperative anal pain after stapled hemorrhoidopexy, clinical evidence of anal hypertonia, and elevated anal resting pressure on manometric assessment were enrolled. Patients treated for concomitant anorectal disease were excluded. INTERVENTIONS: Participants were randomly assigned to receive twice-daily, local topical application of glyceryl trinitrate or lidocaine for a total of 14 days. MAIN OUTCOME MEASURES: Pain intensity was measured on a visual analog scale at baseline and after 2, 7, and 14 days of therapy. Anal resting pressure was measured preand postoperatively and after 14 days of therapy. RESULTS: Of 480 patients undergoing stapled hemorrhoidopexy, 121 had severe postoperative pain (score >3) and underwent clinical examination; 45 patients (13 women, 28 men) had clinically evident anal hypertonia and underwent anorectal manometry; 41 patients had elevated anal resting pressure and entered the study. Mean pain scores were significantly lower with glyceryl trinitrate than with lidocaine on day 2 (2.5 ± 1.0 vs 4.0 ± 1.1, p <0.0001); day 7 (1.4 vs 2.8, p <0.0001); and day 14 (0.4 vs 1.4, p = 0.003). Anal resting pressure was significantly lower with glyceryl trinitrate than with lidocaine on day 14 (75.4 ± 7.4 mmHg vs 85.6 ± 7.9 mmHg, p <0.0001). LIMITATIONS: GTN-induced reduction in sphincter tone could not be evaluated during the initial period, when pain was most intense. Because anorectal manometry was performed only in patients with severe pain and clinical evidence of anal hypertonia, firm conclusions cannot be drawn as to frequency of hypertonia after SH. Bias may have been introduced because the surgical team could not be blinded. CONCLUSION: Topical 0.4% glyceryl trinitrate is effective in relieving pain and reducing anal resting pressure in patients with anal hypertonia after stapled hemorrhoidopexy.

AB - BACKGROUND: Postoperative pain after stapled hemorrhoidopexy is cause for considerable concern and may be related to contracture of continence muscles. OBJECTIVE: We compared glyceryl trinitrate 0.4% ointment with lidocaine chlorohydrate 2.5% gel as topical therapy to relieve the pain of anorectal muscular spasm after stapled hemorrhoidopexy. DESIGN: This was a single-blind, parallel-group, randomized controlled trial. SETTING: The study was conducted at a university teaching hospital in Rome, Italy. PATIENTS: Patients with severe postoperative anal pain after stapled hemorrhoidopexy, clinical evidence of anal hypertonia, and elevated anal resting pressure on manometric assessment were enrolled. Patients treated for concomitant anorectal disease were excluded. INTERVENTIONS: Participants were randomly assigned to receive twice-daily, local topical application of glyceryl trinitrate or lidocaine for a total of 14 days. MAIN OUTCOME MEASURES: Pain intensity was measured on a visual analog scale at baseline and after 2, 7, and 14 days of therapy. Anal resting pressure was measured preand postoperatively and after 14 days of therapy. RESULTS: Of 480 patients undergoing stapled hemorrhoidopexy, 121 had severe postoperative pain (score >3) and underwent clinical examination; 45 patients (13 women, 28 men) had clinically evident anal hypertonia and underwent anorectal manometry; 41 patients had elevated anal resting pressure and entered the study. Mean pain scores were significantly lower with glyceryl trinitrate than with lidocaine on day 2 (2.5 ± 1.0 vs 4.0 ± 1.1, p <0.0001); day 7 (1.4 vs 2.8, p <0.0001); and day 14 (0.4 vs 1.4, p = 0.003). Anal resting pressure was significantly lower with glyceryl trinitrate than with lidocaine on day 14 (75.4 ± 7.4 mmHg vs 85.6 ± 7.9 mmHg, p <0.0001). LIMITATIONS: GTN-induced reduction in sphincter tone could not be evaluated during the initial period, when pain was most intense. Because anorectal manometry was performed only in patients with severe pain and clinical evidence of anal hypertonia, firm conclusions cannot be drawn as to frequency of hypertonia after SH. Bias may have been introduced because the surgical team could not be blinded. CONCLUSION: Topical 0.4% glyceryl trinitrate is effective in relieving pain and reducing anal resting pressure in patients with anal hypertonia after stapled hemorrhoidopexy.

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KW - Anal manometry

KW - Glyceryl trinitrate 0.4% ointment

KW - Pain

KW - Stapled anopexy

KW - Stapled hemorrhoidopexy

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