Botulinum Toxin Injection in Patients Undergoing Hemorrhoidectomy-A Prospective, Randomized Study

The Influence of Timing of Botulinum Toxin Injection on Postoperative Pain Control Clinical Trial

Official title:

The Optimal Timing of Botulinum Toxin Injection for Pain Control in Patients Undergoing Hemorrhoidectomy-A Prospective, Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04485780
• Other study ID #: 1-107-05-042
• Status: Recruiting
• Phase: Phase 4
• Start date: October 8, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2020
• Source: Tri-Service General Hospital
• Contact: Yi-Chiao Cheng
• Phone: +886912959022
• Email: ndmcjoe[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, randomized study, which anticipatedly recruited 60 patients in the outpatient department who need hemorrhoidectomy from January 2019 to December 2019. After obtaining those patients' consent in the clinic, they were randomly assigned to two groups at a 1:1 ratio using a computer-generated list of random numbers (Microsoft Excel). One group received Botulinum toxin injection during the outpatient clinic one week before the operation(experimental group, EG), and the other group received injection during the operation(control group, CG). The two groups were compared for the influence of postoperative pain control and wound healing rate.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients with age over 20 but under 80, who need to undergo hemorrhoidectomy

Exclusion Criteria:

• patients under the age of 20

• patients with nonsteroidal anti-inflammatory drugs (NSAIDs) allergy or sensitivity

• patients with Botulinum toxin allergy or sensitivity

• patients with dialysis or renal insufficiency

• pregnant and breastfeeding women

• vulnerable population

Related Conditions & MeSH terms

• Pain, Postoperative
• The Influence of Timing of Botulinum Toxin Injection on Postoperative Pain Control

Intervention

Biological:
• botulinum toxin type A
In the outpatient department, patients who need hemorrhoidectomy were randomly assigned to two groups at a 1:1 ratio using a computer-generated list of random numbers (Microsoft Excel). One group received Botulinum toxin injection during the outpatient clinic one week before the operation(experimental group, EG), and the other group received injection during the operation(control group, CG). The two groups were compared for the influence of postoperative pain control and wound healing rate.

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital, National Defense Medical Center	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	one week after operation	The degree of postoperative pain is assessed by visual analog scale (VAS). After operation, we record patients' average VAS score and maximum VAS score every day until one week after surgery.	1 weel