Ilioinguinal Block in Laparoscopic Inguinal Hernia Repair

December 16, 2014 updated by: Thorbjorn Sommer, Randers Regional Hospital

Effect of Ilioinguinal Blockage on Postoperative Pain After Laparoscopic Inguinal Herna Repair

This study is undertaken to clarify whether intraoperative blockage with 40 ml of ½ % Marcaine© of the nerves in the ilio-inguinal canal may decrease postoperative pain after laparoscopic inguinal hernia repair.

Patients will be randomised to injection of Marcaine© og a needle prick per-operatively.

Pain will be estimated using the VAS score in:

1. the wound 2 the abdomen 3 the shoulder

Scoring will be performed:

  1. pre-operatively
  2. 1 hour postoperatively
  3. at discharge from the hospital d day 1,2 and 3 post OP

e. 1 year post OP

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

as above

Study Type

Interventional

Phase

  • Phase 2

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
      • Horsens, Denmark, 8700
        • Horsens Regions Hospital
      • Randers, Denmark, 8900
        • Randers regions Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Age ≥ 18 year
  2. Informed consent
  3. a diagnosis of an inguinal hernia
  4. ASA group ≤ 3
  5. BMI ≤ 35

Exclusion Criteria:

  1. Communication problems
  2. No consent
  3. Open procedure (not laparoscopic)
  4. ASA-group 4
  5. Use of Steroid or immunosuppressive tretament
  6. Regular morphine use.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Injection of Marcaine ½ %
Injection of 40 ml of Marcaine ½ % 2 cm medial, 2 cm downwards from the Anterior Iliac Spine
Drug: Marcaine ½%
Placebo Comparator: Needle prick
Needle prick 2 cm medial and 2 cm downwards from the Anterior Iliac spine
Procedure: Needle prick

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative pain
Time Frame: 1 year

VAS score of pain from:

  1. wound
  2. abdomen
  3. shoulder
1 year

Collaborators and Investigators

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

Sponsor

Randers Regional Hospital

Collaborators

Regionshospitalet Horsens
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

January 1, 2014

Primary Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

October 21, 2013

First Posted (Estimate)

October 24, 2013

Study Record Updates

Last Update Posted (Estimate)

December 17, 2014

Last Update Submitted That Met QC Criteria

December 16, 2014

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILIOINGUINAL01

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.

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