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Perianal Nerval Block in Proctological Interventions

Primary Purpose

Perianal Fistula, Fissure in Ano, Hemorrhoids

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Placebo 40 mL Saline 0.9%
40 mL Ropivacain 0.5%
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perianal Fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St Claraspital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Ropivacain

Arm Description

Placebo 40 mL Saline 0.9%

40 mL Ropivacain 0.5%

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Quality of Life assessed by questionnaire
Quality of Life assessed by questionnaire

Full Information

First Posted
January 12, 2018
Last Updated
July 9, 2019
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT03405922
Brief Title
Perianal Nerval Block in Proctological Interventions
Official Title
Perianal Nerval Block in Proctological Interventions: a Prospective Randomized Double Blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
July 5, 2019 (Actual)
Study Completion Date
July 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perianal Fistula, Fissure in Ano, Hemorrhoids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 40 mL Saline 0.9%
Arm Title
Ropivacain
Arm Type
Active Comparator
Arm Description
40 mL Ropivacain 0.5%
Intervention Type
Drug
Intervention Name(s)
Placebo 40 mL Saline 0.9%
Intervention Description
Injection of 40 mL 0.9% saline
Intervention Type
Drug
Intervention Name(s)
40 mL Ropivacain 0.5%
Intervention Description
Ropivacaine Hcl 0.5% Injection 40 mL
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
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 Outcome Measure Information:
Title
Quality of Life assessed by questionnaire
Description
Quality of Life assessed by questionnaire
Time Frame
2 weeks post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Steinemann
Organizational Affiliation
St:Claraspital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Claraspital
City
Basel
ZIP/Postal Code
4016
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32187663
Citation
Rotigliano N, Fuglistaler I, Guenin MO, Dursunoglu GB, Freiermuth D, von Flue M, Steinemann DC. Perianal block with ropivacaine as a supplement to anaesthesia in proctological surgery: double-blind randomized placebo-controlled trial (PERCEPT). Br J Surg. 2020 Jul;107(8):960-969. doi: 10.1002/bjs.11520. Epub 2020 Mar 18.
Results Reference
derived

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Perianal Nerval Block in Proctological Interventions

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