Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair
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ClinicalTrials.gov Identifier: NCT01170780 |
Recruitment Status :
Completed
First Posted : July 27, 2010
Last Update Posted : January 31, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Inguinal Hernia Femoral Hernia | Drug: Dexamethasone Drug: Saline | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
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 |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | August 2011 |
Arm | Intervention/treatment |
---|---|
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 |
- pain during coughing [ Time Frame: day 1 ]Assessed with visual analog scale (VAS 0-100 mm)
- 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)

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

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
Denmark | |
University Hospital Koege | |
Koege, Denmark, 4600 |
Principal Investigator: | Mette A Tolver, M.D. | University Hospital Koege | |
Principal Investigator: | Thue Bisgaard, M.D. DMSc | University Hospital Koege |
Responsible Party: | Mette Astrup Madsen, M.D., Zealand University Hospital |
ClinicalTrials.gov Identifier: | NCT01170780 |
Other Study ID Numbers: |
dx3 |
First Posted: | July 27, 2010 Key Record Dates |
Last Update Posted: | January 31, 2012 |
Last Verified: | January 2012 |
Inguinal hernia Transabdominal preperitoneal hernia repair TAPP Dexamethasone Pain |
Hernia Hernia, Inguinal Hernia, Femoral Pathological Conditions, Anatomical Hernia, Abdominal Dexamethasone 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 |