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Completed

NCT Number: NCT01170780

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.

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Key information

Conditions

Inguinal Hernia Femoral Hernia Hernia Hernia, Abdominal Hernia, Femoral Hernia, Inguinal Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Koege

Koege, 4600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

single use of dexamethasone IV 8 mg/2 ml

Other names: Fortecontin

Saline

Drug

2 ml IV

Other names: Natriumchlorid, B. Braun 9 mg/ml

Primary outcomes

  1. pain during coughing

    Time frame: day 1

    Assessed with visual analog scale (VAS 0-100 mm)

Secondary outcomes

  1. pain during coughing

    Time frame: 4 days

    Assessed with VAS

  2. pain at rest

    Time frame: 4 days

    Assessed with VAS

  3. convalescence

    Time frame: 1 month

    Registration of number of days after operation before returning to work and recreational activities.

  4. pain at rest

    Time frame: 4 days

    Assessed with verbal rating scale (VRS:no pain, mild pain, severe pain, worst thinkable pain)

  5. nausea

    Time frame: 2 days

    Assessed with verbal rating scale (VRS: no nausea, mild nausea, severe nausea, worst thinkable nausea)

  6. vomiting

    Time frame: 2 days

    yes/no question. If yes, how many times have you been vomiting?

  7. discomfort

    Time frame: 4 days

    Assessed with visual analog scale (VAS, 0-100 mm)

  8. fatigue

    Time frame: 4 days

    Assessed with numeric rating scale (NRS, 1-10)

Sponsors and collaborators

Lead sponsor

Mette Astrup Madsen

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 27, 2010
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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