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

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01170780
• Other study ID #: dx3
• 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

Related Conditions & MeSH terms

• Femoral Hernia
• Hernia
• Hernia, Femoral
• Hernia, Inguinal
• Inguinal Hernia

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