Trial of steroids during hernia repair

ISRCTN	ISRCTN92062343
DOI	https://doi.org/10.1186/ISRCTN92062343
Protocol serial number	EU-nr 2004-004280-30
Sponsor	Dalarna Research Institute (Dalarnas forskningsråd [DFR]) (Sweden)
Funder	Dalarna Research Institute (Dalarnas forskningsråd [DFR]) (Sweden)

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

Dept of Gastrointestinal Surgery
Karolinska University Hospital / Huddinge
141 86 Stockholm
Sweden
Stockholm
141 86
Sweden

Phone	+46 (0)70 415 82 18
Email	gabriel.sandblom@ki.se

Study information

Primary study design	Interventional
Study design	Double blind randomised placebo controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes