Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair

August 22, 2024 updated by: Mette Astrup Madsen
Does corticosteroid (dexamethasone) have an effect on the postoperative period after laparoscopic hernia repair, when it comes to pain, postoperative nausea and vomiting and convalescence. This randomized, double-blinded study compares dexamethasone versus placebo. The patients are recommended one day of convalescence. The medicine or placebo is given before operation. The patients fill out questionnaire before operation and three hours after operation and in the following three days. The patients also register when they return to normal activities and work.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

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
      • Koege, Denmark, 4600
        • University Hospital Koege

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

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients planned for elective laparoscopic hernia repair (TAPP)
  • Unilateral inguinal or femoral hernia
  • ASA class I-II
  • Read and speak Danish

Exclusion Criteria:

  • Acute hernia operation
  • Operation for other hernias with mesh during the same procedure
  • Endocrine disease (diabetes, adrenal insufficiency etc.)
  • fever/infection within the first 10 days before operation
  • Poor compliance
  • No signed consent form
  • Daily intake of opioids or anxiolytic drugs
  • Manic episodes
  • Use medicine against glaucoma
  • Use thiazide or loop diuretics
  • Vaccination within the last 14 days

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
Placebo Comparator: Placebo
Saline
Drug: Saline
2 ml IV
Other Names:
  • Natriumchlorid, B. Braun 9 mg/ml
Active Comparator: Dexamethasone
Corticosteroid (Fortecontin 8 mg)
Drug: Dexamethasone
single use of dexamethasone IV 8 mg/2 ml
Other Names:
  • Fortecontin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain during coughing
Time Frame: day 1
Assessed with visual analog scale (VAS 0-100 mm)
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain during coughing
Time Frame: 4 days
Assessed with VAS
4 days
pain at rest
Time Frame: 4 days
Assessed with VAS
4 days
convalescence
Time Frame: 1 month
Registration of number of days after operation before returning to work and recreational activities.
1 month
pain at rest
Time Frame: 4 days
Assessed with verbal rating scale (VRS:no pain, mild pain, severe pain, worst thinkable pain)
4 days
nausea
Time Frame: 2 days
Assessed with verbal rating scale (VRS: no nausea, mild nausea, severe nausea, worst thinkable nausea)
2 days
vomiting
Time Frame: 2 days
yes/no question. If yes, how many times have you been vomiting?
2 days
discomfort
Time Frame: 4 days
Assessed with visual analog scale (VAS, 0-100 mm)
4 days
fatigue
Time Frame: 4 days
Assessed with numeric rating scale (NRS, 1-10)
4 days

Collaborators and Investigators

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

Sponsor

Mette Astrup Madsen

Investigators

  • Principal Investigator: Mette A Tolver, M.D., University Hospital Koege
  • Principal Investigator: Thue Bisgaard, M.D. DMSc, University Hospital Koege

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

July 26, 2010

First Submitted That Met QC Criteria

July 26, 2010

First Posted (Estimated)

July 27, 2010

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 22, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dx3

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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