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ISRCTN
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ISRCTN92062343
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ClinicalTrials.gov identifier
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Public title
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Trial of steroids during hernia repair
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Scientific title
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Randomised controlled trial of betamethasone versus placebo during open hernia repair
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Acronym
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Betopher
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Serial number at source
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EU-nr 2004-004280-30
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Study hypothesis
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Betamethasone reduces postoperative pain and nausea after hernia repair.
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Lay summary
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Ethics approval
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Uppsala Review Board approved on the 19th August 2004 (ref: 2004:M-029)
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Study design
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Double blind randomised placebo controlled trial
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Countries of recruitment
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Sweden
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Disease/condition/study domain
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Pain after groin hernia repair
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Participants - inclusion criteria
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Patients aged 18 - 70 years undergoing open surgery for groin hernia
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Participants - exclusion criteria
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Allergy to:
1. Paracetamol
2. Non-steroidal anti-inflammatory drugs (NSAID)
3. Sulfonamide antibiotics
4. Salicylate
5. Betamethasone
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Anticipated start date
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01/01/2006
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Anticipated end date
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31/12/2008
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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400
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Interventions
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Patients are randomised to receive:
1. Betamethasone: 12 mg by intravenous injection at the induction of anaesthesia
2. Placebo: sodium chloride injection fluid at the induction of anaestheia
After the initial injection, anaesthesia is conducted according to the usual routines.
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Primary outcome measure(s)
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Post-operative pain and nausea. Every half an hour postoperatively the level of pain is assessed using a visual analogue scale (VAS). Intake of food and drink, nausea or vomiting, VAS score when mobilised, medication, time for mobilisation and discharge from the unit are also recorded.
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Secondary outcome measure(s)
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1. Time to discharge
2. Need of analgetics
3. Long-term postoperative pain
By discharge the patient receives a questionnaire to be recorded the first seven postoperative days. The patient is requested to record the daily use of medicines, the minimal and maximal VAS score for pain, ability to eat and drink, mobilisation, nausea, vomiting, or any other postoperative adverse events. The day after surgery the patient is contacted by phone and asked about VAS score for pain, ability to drink and eat, nausea, and mobilisation. One month after the operation the patient is contacted a second time by phone and asked about the presence of pain, any use of analgesics, problems related to the operation, and ability to perform normal working activity.
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Sources of funding
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Dalarna Research Institute (Dalarnas forskningsråd [DFR]) (Sweden)
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Trial website
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Publications
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Contact name
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Dr
Gabriel
Sandblom
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Address
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Dept of Gastrointestinal Surgery
Karolinska University Hospital / Huddinge
141 86 Stockholm
Sweden
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City/town
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Stockholm
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Zip/Postcode
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141 86
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Country
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Sweden
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Tel
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+46 (0)70 415 82 18
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Fax
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+46 (0)8 58 58 69 10
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Email
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gabriel.sandblom@ki.se
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Sponsor
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Dalarna Research Institute (Dalarnas forskningsråd [DFR]) (Sweden)
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Address
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Kommunernas Hus i Falun
Myntgatan 2
791 51 Falun
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City/town
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Falun
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Zip/Postcode
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791 51
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Country
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Sweden
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Tel
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+46 (0)23 70 91 00
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Fax
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+46 (0)23 70 91 89
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Email
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info@dfr.se
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Sponsor website:
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http://www.dfr.se/
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Date applied
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21/06/2010
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Last edited
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11/08/2010
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Date ISRCTN assigned
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11/08/2010
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