Perianal Nerval Block in Proctological Interventions

University Hospital, Basel, Switzerland166 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

166

Conditions

Perianal Fistula Fissure in Ano Hemorrhoids

Interventions

Placebo 40 mL Saline 0.9%DRUG

Injection of 40 mL 0.9% saline

40 mL Ropivacain 0.5%DRUG

Ropivacaine Hcl 0.5% Injection 40 mL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

St Claraspital

Basel, Switzerland

Outcomes

Primary Outcomes

Postoperative Pain

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)

Time frame: 24 hours post-surgery

Secondary Outcomes

Quality of Life assessed by questionnaire

Time frame: 2 weeks post-surgery

Data from ClinicalTrials.gov

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