Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair
This study has been completed.
Sponsor:
Mette Astrup Madsen
ClinicalTrials.gov Identifier:
NCT01170780
First Posted: July 27, 2010
Last Update Posted: January 31, 2012
Information provided by (Responsible Party):
Mette Astrup Madsen, University Hospital Koge
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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 Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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:
Further study details as provided by Mette Astrup Madsen, University Hospital Koge:
Primary Outcome Measures:
- pain during coughing [ Time Frame: day 1 ]Assessed with visual analog scale (VAS 0-100 mm)
Secondary Outcome Measures:
- pain during coughing [ Time Frame: 4 days ]Assessed with VAS
- pain at rest [ Time Frame: 4 days ]Assessed with VAS
- convalescence [ Time Frame: 1 month ]Registration of number of days after operation before returning to work and recreational activities.
- pain at rest [ Time Frame: 4 days ]Assessed with verbal rating scale (VRS:no pain, mild pain, severe pain, worst thinkable pain)
- nausea [ Time Frame: 2 days ]Assessed with verbal rating scale (VRS: no nausea, mild nausea, severe nausea, worst thinkable nausea)
- vomiting [ Time Frame: 2 days ]yes/no question. If yes, how many times have you been vomiting?
- discomfort [ Time Frame: 4 days ]Assessed with visual analog scale (VAS, 0-100 mm)
- fatigue [ Time Frame: 4 days ]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
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| Sexes 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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):
| Responsible Party: | Mette Astrup Madsen, M.D., University Hospital Koge |
| ClinicalTrials.gov Identifier: | NCT01170780 History of Changes |
| Other Study ID Numbers: |
dx3 |
| First Submitted: | July 26, 2010 |
| First Posted: | July 27, 2010 |
| Last Update Posted: | January 31, 2012 |
| Last Verified: | January 2012 |
Keywords provided by Mette Astrup Madsen, 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 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 |