Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair - Full Text View

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:

MedlinePlus related topics: Hernia Nausea and Vomiting

Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Dexamethasone acetate

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Tolver MA, Strandfelt P, Bryld EB, Rosenberg J, Bisgaard T. Randomized clinical trial of dexamethasone versus placebo in laparoscopic inguinal hernia repair. Br J Surg. 2012 Oct;99(10):1374-80. doi: 10.1002/bjs.8876.


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, Inguinal Hernia, Femoral Pathological Conditions, Anatomical Hernia, Abdominal Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents	Peripheral Nervous System Agents Physiological Effects of Drugs 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 September 29, 2016