Ultrasound-guided Ilioinguinal-iliohypogastric Block for Inguinal Hernia Repair

March 29, 2011 updated by: Bispebjerg Hospital

Does Ultrasound-guided Ilioinguinal-iliohypogastric Block Improve Postoperative Pain Outcome After Unilateral Inguinal Hernia Repair?

Aim: To investigate whether ultrasound-guided perineural administration of 20 ml bupivacaine 5 mg/ml vs 20 ml isotonic saline at the ilioinguinal-iliohypogastric nerves have a clinically analgesic effect after unilateral open inguinal hernia repair.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • NV
      • Copenhagen, NV, Denmark, 2400
        • Recruiting
        • Copenhagen University Hospital Bispebjerg
        • Contact:
        • Contact:
        • Principal Investigator:
          • Finn Bærentzen, MD
        • Sub-Investigator:
          • Jens Børglum, MD
        • Sub-Investigator:
          • Kenneth Jensen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • age above 18 years
  • unilateral primary inguinal repair
  • open surgery a.m. Lichtenstein
  • informed consent

Exclusion Criteria:

  • age below 18 years
  • secondary surgery
  • laparoscopic surgery
  • lack of communicative skills

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: bupivacaine
perineural bupivacaine 5 mg/ml 20 ml
Drug: bupivacaine
perineural bupivacaine 5 mg/ml 20 ml
Placebo Comparator: saline
perineural isotonic saline 20 ml
Drug: saline
perineural isotonic saline 20 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain at mobilization using 100 mm VAS
Time Frame: within the first 24 hours postoperatively
within the first 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain at rest using 100 mm VAS
Time Frame: within 24 hours postoperatively
within 24 hours postoperatively
perceived illness
Time Frame: within 24 hours postoperatively
using short form-8 index
within 24 hours postoperatively
ability of daily living
Time Frame: within 24 hours
using the Barthel/100 index
within 24 hours
amount of analgesics
Time Frame: within 24 hours postoperatively
within 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Investigators

  • Study Chair: Kenneth Jensen, MD, Copenhagen University Hospital Bispebjerg, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

July 1, 2011

Study Registration Dates

First Submitted

March 28, 2011

First Submitted That Met QC Criteria

March 29, 2011

First Posted (Estimate)

March 30, 2011

Study Record Updates

Last Update Posted (Estimate)

March 30, 2011

Last Update Submitted That Met QC Criteria

March 29, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBH_2010_IIH

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inguinal Hernia

Clinical Trials on bupivacaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe