Perianal Nerval Block in Proctological Interventions

Hemorrhoids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03405922
• Other study ID #: Perianal block in proctology
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2018
• Est. completion date: July 5, 2019

Study information

• Verified date: July 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: July 5, 2019
• Est. primary completion date: July 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fissure in Ano
• Fistula
• Hemorrhoids
• Perianal Fistula

Intervention

Drug:
• Placebo 40 mL Saline 0.9%
Injection of 40 mL 0.9% saline
• 40 mL Ropivacain 0.5%
Ropivacaine Hcl 0.5% Injection 40 mL

Locations

Country	Name	City	State
Switzerland	St Claraspital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	24 hours post-surgery
Secondary	Quality of Life assessed by questionnaire	Quality of Life assessed by questionnaire	2 weeks post-surgery