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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01170780
Other study ID # dx3
Secondary ID
Status Completed
Phase Phase 3
First received July 26, 2010
Last updated January 26, 2012
Start date August 2010
Est. completion date August 2011

Study information

Verified date January 2012
Source University Hospital Koge
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Drug:
Dexamethasone
single use of dexamethasone IV 8 mg/2 ml
Saline
2 ml IV

Locations

Country Name City State
Denmark University Hospital Koege Koege

Sponsors (1)

Lead Sponsor Collaborator
Mette Astrup Madsen

Country where clinical trial is conducted

Denmark, 

Outcome

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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