Inguinal Hernia Clinical Trial
Official title:
Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | August 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Denmark | University Hospital Koege | Koege |
Lead Sponsor | Collaborator |
---|---|
Mette Astrup Madsen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pain during coughing | Assessed with visual analog scale (VAS 0-100 mm) | day 1 | No |
Secondary | pain during coughing | Assessed with VAS | 4 days | No |
Secondary | pain at rest | Assessed with VAS | 4 days | No |
Secondary | convalescence | Registration of number of days after operation before returning to work and recreational activities. | 1 month | No |
Secondary | pain at rest | Assessed with verbal rating scale (VRS:no pain, mild pain, severe pain, worst thinkable pain) | 4 days | No |
Secondary | nausea | Assessed with verbal rating scale (VRS: no nausea, mild nausea, severe nausea, worst thinkable nausea) | 2 days | No |
Secondary | vomiting | yes/no question. If yes, how many times have you been vomiting? | 2 days | No |
Secondary | discomfort | Assessed with visual analog scale (VAS, 0-100 mm) | 4 days | No |
Secondary | fatigue | Assessed with numeric rating scale (NRS, 1-10) | 4 days | No |
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