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

Mette Astrup Madsen

Status and phase: Completed; Phase 3

Conditions: Femoral Hernia; Inguinal Hernia

Treatments: Drug: Dexamethasone; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01170780

dx3

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Saline

Treatment:

Drug: Saline

Dexamethasone

Active Comparator group

Description:

Corticosteroid (Fortecontin 8 mg)

Treatment:

Drug: Dexamethasone