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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01170780

Enrollment

Registered

2010-07-27

Start date

2010-08-31

Completion date

2011-08-31

Last updated

2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Hernia, Inguinal Hernia

Keywords

Inguinal hernia, Transabdominal preperitoneal hernia repair, TAPP, Dexamethasone, Pain

Brief 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.

Interventions

DRUGDexamethasone

single use of dexamethasone IV 8 mg/2 ml

DRUGSaline

2 ml IV

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 85 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026