Trial of steroids during hernia repair
| ISRCTN | ISRCTN92062343 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92062343 |
| Secondary identifying numbers | EU-nr 2004-004280-30 |
- Submission date
- 21/06/2010
- Registration date
- 11/08/2010
- Last edited
- 11/08/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Gabriel Sandblom
Scientific
Scientific
Dept of Gastrointestinal Surgery
Karolinska University Hospital / Huddinge
141 86 Stockholm
Sweden
Stockholm
141 86
Sweden
| Phone | +46 (0)70 415 82 18 |
|---|---|
| gabriel.sandblom@ki.se |
Study information
| Study design | Double blind randomised placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Randomised controlled trial of betamethasone versus placebo during open hernia repair |
| Study acronym | Betopher |
| Study objectives | Betamethasone reduces postoperative pain and nausea after hernia repair. |
| Ethics approval(s) | Uppsala Review Board approved on the 19th August 2004 (ref: 2004:M-029) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2006 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 400 |
| Key inclusion criteria | Patients aged 18 - 70 years undergoing open surgery for groin hernia |
| Key exclusion criteria | Allergy to: 1. Paracetamol 2. Non-steroidal anti-inflammatory drugs (NSAID) 3. Sulfonamide antibiotics 4. Salicylate 5. Betamethasone |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Dept of Gastrointestinal Surgery
Stockholm
141 86
Sweden
141 86
Sweden
Sponsor information
Dalarna Research Institute (Dalarnas forskningsråd [DFR]) (Sweden)
Research council
Research council
Kommunernas Hus i Falun
Myntgatan 2
791 51 Falun
Falun
791 51
Sweden
| Phone | +46 (0)23 70 91 00 |
|---|---|
| info@dfr.se | |
| Website | http://www.dfr.se/ |
Funders
Funder type
Research council
Dalarna Research Institute (Dalarnas forskningsråd [DFR]) (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
