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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mette Astrup Madsen, University Hospital Koge
ClinicalTrials.gov Identifier:
NCT01170780
First received: July 26, 2010
Last updated: January 26, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Inguinal Hernia
Femoral Hernia
 Drug: Dexamethasone
Drug: Saline
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Koge:

Primary Outcome Measures:
  • pain during coughing [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    Assessed with visual analog scale (VAS 0-100 mm)


Secondary Outcome Measures:
  • pain during coughing [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Assessed with VAS

  • pain at rest [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Assessed with VAS

  • convalescence [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Registration of number of days after operation before returning to work and recreational activities.

  • pain at rest [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Assessed with verbal rating scale (VRS:no pain, mild pain, severe pain, worst thinkable pain)

  • nausea [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Assessed with verbal rating scale (VRS: no nausea, mild nausea, severe nausea, worst thinkable nausea)

  • vomiting [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    yes/no question. If yes, how many times have you been vomiting?

  • discomfort [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Assessed with visual analog scale (VAS, 0-100 mm)

  • fatigue [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Assessed with numeric rating scale (NRS, 1-10)


Enrollment: 80
Study Start Date: August 2010
Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Saline
 Drug: Saline
2 ml IV
Other Name: Natriumchlorid, B. Braun 9 mg/ml
Active Comparator: Dexamethasone
Corticosteroid (Fortecontin 8 mg)
 Drug: Dexamethasone
single use of dexamethasone IV 8 mg/2 ml
Other Name: Fortecontin

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170780

Locations
Denmark
University Hospital Koege
Koege, Denmark, 4600
Sponsors and Collaborators
Mette Astrup Madsen
Investigators
Principal Investigator: Mette A Tolver, M.D. University Hospital Koege
Principal Investigator: Thue Bisgaard, M.D. DMSc University Hospital Koege
  More Information

No publications provided by University Hospital Koge

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mette Astrup Madsen, M.D., University Hospital Koge
ClinicalTrials.gov Identifier: NCT01170780     History of Changes
Other Study ID Numbers: dx3
Study First Received: July 26, 2010
Last Updated: January 26, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by University Hospital Koge:
Inguinal hernia
Transabdominal preperitoneal hernia repair
TAPP
Dexamethasone
Pain

Additional relevant MeSH terms:
Hernia
Hernia, Femoral
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013