Condition category
Surgery
Date applied
21/06/2010
Date assigned
11/08/2010
Last edited
11/08/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dfr.se/

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

Publication citations

Additional files

Editorial Notes