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

Study Overview
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Brief Summary
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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.

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

Conditions
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Inguinal Hernia, Femoral Hernia

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Saline | Drug: Saline<br>* 2 ml IV<br>* Other names: Natriumchlorid, B. Braun 9 mg/ml;|
| Active Comparator: Dexamethasone<br>Corticosteroid (Fortecontin 8 mg) | Drug: Dexamethasone<br>* single use of dexamethasone IV 8 mg/2 ml<br>* Other names: Fortecontin;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inguinal hernia, Transabdominal preperitoneal hernia repair, TAPP, Dexamethasone, Pain