Contact information
Type
Scientific
Primary contact
Dr Gabriel Sandblom
ORCID ID
Contact details
Dept of Gastrointestinal Surgery
Karolinska University Hospital / Huddinge
141 86 Stockholm
Sweden
Stockholm
141 86
Sweden
+46 (0)70 415 82 18
gabriel.sandblom@ki.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EU-nr 2004-004280-30
Study information
Scientific title
Randomised controlled trial of betamethasone versus placebo during open hernia repair
Acronym
Betopher
Study hypothesis
Betamethasone reduces postoperative pain and nausea after hernia repair.
Ethics approval
Uppsala Review Board approved on the 19th August 2004 (ref: 2004:M-029)
Study design
Double blind randomised placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Pain after groin hernia repair
Intervention
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.
Intervention type
Procedure/Surgery
Phase
Phase III
Drug names
Primary outcome measures
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.
Secondary outcome measures
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.
Overall trial start date
01/01/2006
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Patients aged 18 - 70 years undergoing open surgery for groin hernia
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
Allergy to:
1. Paracetamol
2. Non-steroidal anti-inflammatory drugs (NSAID)
3. Sulfonamide antibiotics
4. Salicylate
5. Betamethasone
Recruitment start date
01/01/2006
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Sweden
Trial participating centre
Dept of Gastrointestinal Surgery
Stockholm
141 86
Sweden
Sponsor information
Organisation
Dalarna Research Institute (Dalarnas forskningsråd [DFR]) (Sweden)
Sponsor details
Kommunernas Hus i Falun
Myntgatan 2
791 51 Falun
Falun
791 51
Sweden
+46 (0)23 70 91 00
info@dfr.se
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Dalarna Research Institute (Dalarnas forskningsråd [DFR]) (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary