Perianal Nerval Block in Proctological Interventions

Phase 4

Completed

• Conditions: Perianal Fistula; Fissure in Ano; Hemorrhoids
• Interventions: Drug: Placebo 40 mL Saline 0.9%; Drug: 40 mL Ropivacain 0.5%

• Registration Number: NCT03405922
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

The aim of this study is to evaluate whether a local perianal block performed during a proctological intervention can reduce the postoperative pain.

Detailed Description

The aim of this study is to evaluate whether a local perianal block performed during a proctological intervention can reduce the postoperative pain.

All patients will undergo surgery under general or spinal anesthesia. At the end of the surgery, the surgeon will perform a perianal block using the local anesthetic or the placebo upon randomisation. The experimental group will receive a local anesthetics and the control group a normal saline injection. All injections will be perianal, peripheral to the external anal sphincter.

Study Timeline

• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-01-12
• Study First Posted: 2018-01-23
• Study Start: 2018-02-01
• Status Verified: 2019-07
• Primary Completion: 2019-07-05
• Study Completion: 2019-07-05
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

• Patients with surgical indication for hemorrhoids, fistula-in-ano or anal fissures.
• Age of 18 or above

Exclusion Criteria

• age under 18.
• Patients unable to understand an informed consent.
• Emergency operations
• Pregnant women.
• Patients with acute perianal infection.
• Patients allergic to any component of the local anesthetic

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo 40 mL Saline 0.9%	Placebo 40 mL Saline 0.9%
Ropivacain	40 mL Ropivacain 0.5%	40 mL Ropivacain 0.5%

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	24 hours post-surgery	Postoperative Pain assessed by visual analogue scale (max. 10, min.0 points, range: 0-10; 0 = no pain at all, 10 = worst pain ever experienced)

Secondary Outcome Measures

Name	Time	Method
Quality of Life assessed by questionnaire	2 weeks post-surgery	Quality of Life assessed by questionnaire

Trial Locations

Locations (1)

St Claraspital; 🇨🇭 Basel, Switzerland