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Perianal Nerval Block in Proctological Interventions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03405922
Recruitment Status : Completed
First Posted : January 23, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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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.

Condition or disease Intervention/treatment Phase
Perianal Fistula Fissure in Ano Hemorrhoids Drug: Placebo 40 mL Saline 0.9% Drug: 40 mL Ropivacain 0.5% Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Perianal Nerval Block in Proctological Interventions: a Prospective Randomized Double Blinded Study
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : July 5, 2019
Actual Study Completion Date : July 5, 2019
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo 40 mL Saline 0.9%
 Drug: Placebo 40 mL Saline 0.9%
Injection of 40 mL 0.9% saline
Active Comparator: Ropivacain
40 mL Ropivacain 0.5%
 Drug: 40 mL Ropivacain 0.5%
Ropivacaine Hcl 0.5% Injection 40 mL


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Quality of Life assessed by questionnaire [ Time Frame: 2 weeks post-surgery ]
    Quality of Life assessed by questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405922


Locations
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Switzerland
St Claraspital
Basel, Switzerland, 4016
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Daniel Steinemann St:Claraspital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03405922    
Other Study ID Numbers: Perianal block in proctology
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Hemorrhoids
Fissure in Ano
Fistula
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Anus Diseases