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

Phase 3

Completed

• Conditions: Inguinal Hernia; Femoral Hernia
• Interventions: Drug: Saline; Drug: Dexamethasone

• Registration Number: NCT01170780
• Lead Sponsor: Mette Astrup Madsen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2010-07-26
• Study First Posted: 2010-07-27
• Study Start: 2010-08
• Primary Completion: 2011-06
• Study Completion: 2011-08
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	Saline
Dexamethasone	Dexamethasone	Corticosteroid (Fortecontin 8 mg)

Primary Outcome Measures

Name	Time	Method
pain during coughing	day 1	Assessed with visual analog scale (VAS 0-100 mm)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Koege; 🇩🇰 Koege, Denmark