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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Saline |
|
| Dexamethasone | Active Comparator | Corticosteroid (Fortecontin 8 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | single use of dexamethasone IV 8 mg/2 ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| pain during coughing | Assessed with visual analog scale (VAS 0-100 mm) | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| pain during coughing | Assessed with VAS | 4 days |
| pain at rest | Assessed with VAS | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mette A Tolver, M.D. | University Hospital Koege | Principal Investigator |
| Thue Bisgaard, M.D. DMSc | University Hospital Koege | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Koege | Koege | 4600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22961516 | Derived | 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. |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D006550 | Hernia, Femoral |
| D010146 | Pain |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Saline | Drug | 2 ml IV |
|
|
| convalescence | Registration of number of days after operation before returning to work and recreational activities. | 1 month |
| pain at rest | Assessed with verbal rating scale (VRS:no pain, mild pain, severe pain, worst thinkable pain) | 4 days |
| nausea | Assessed with verbal rating scale (VRS: no nausea, mild nausea, severe nausea, worst thinkable nausea) | 2 days |
| vomiting | yes/no question. If yes, how many times have you been vomiting? | 2 days |
| discomfort | Assessed with visual analog scale (VAS, 0-100 mm) | 4 days |
| fatigue | Assessed with numeric rating scale (NRS, 1-10) | 4 days |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |