Perianal Nerval Block in Proctological Interventions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-07-05

Brief Summary

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

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Detailed Description

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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.

Conditions

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Perianal Fistula Fissure in Ano Hemorrhoids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Placebo

Placebo 40 mL Saline 0.9%

Group Type PLACEBO_COMPARATOR

Placebo 40 mL Saline 0.9%

Intervention Type DRUG

Injection of 40 mL 0.9% saline

Ropivacain

40 mL Ropivacain 0.5%

Group Type ACTIVE_COMPARATOR

40 mL Ropivacain 0.5%

Intervention Type DRUG

Ropivacaine Hcl 0.5% Injection 40 mL

Interventions

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Placebo 40 mL Saline 0.9%

Injection of 40 mL 0.9% saline

Intervention Type DRUG

40 mL Ropivacain 0.5%

Ropivacaine Hcl 0.5% Injection 40 mL

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No