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NCT Number: NCT03405922

Perianal Nerval Block in Proctological Interventions

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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Key information

Conditions

Perianal Fistula Anus Diseases Cardiovascular Diseases Digestive System Diseases Fissure in Ano Gastrointestinal Diseases Hemorrhoids Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St Claraspital

Basel, 4016, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Postoperative Pain

    Time frame: 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 outcomes

  1. Quality of Life assessed by questionnaire

    Time frame: 2 weeks post-surgery

    Quality of Life assessed by questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Perianal Nerval Block in Proctological Interventions: a Prospective Randomized Double Blinded Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2018
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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