Effects of subfascial infiltration of 0.25% bupivacaine versus N/saline in elective abdominal surgery: a randomised controlled trial.
| ISRCTN | ISRCTN12037208 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12037208 |
| Secondary identifying numbers | N0234126586 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 25/10/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Signs and Symptoms
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
Mr A R Dixon
Scientific
Scientific
Department of Surgery
North Bristol NHS Trust
Frenchay Hospital
Frenchay
Bristol
BS16 1ND
United Kingdom
| Phone | +44 (0)117 970 1212 |
|---|---|
| anthony.dixon@north-bristol.swest.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Scientific title | Effects of subfascial infiltration of 0.25% bupivacaine versus N/saline in elective abdominal surgery: a randomised controlled trial. |
| Study objectives | The effects of subfascial infiltration of 0.25% bupivacaine versus N/saline in elective abdominal surgery: a randomised controlled trial. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Post-operative pain |
| Intervention | Patients will undergo a simple non-invasive pulmonary function test carried out at the patients bedside and repeated each morning for the first 7 days postoperatively. Added August 2008: trial stopped. |
| Intervention type | Other |
| Primary outcome measure | Surgery pain scores. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 30/05/2003 |
| Completion date | 30/10/2003 |
| Reason abandoned (if study stopped) | Lack of staff |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Not Specified |
| Target number of participants | 80 |
| Key inclusion criteria | All patients who require abdominal surgery (midline laparotomy) and are aged between 18-90 will be entered into the study excluding the following: History of drug abuse, chronic pain, regular medication with opioids/non-steroidal anti-inflammatory drugs (NSAIDs), diabetes, morbid obesity, unable to use patient controlled analgesia (PCA). A total of 80 patients will be studied, 40 in each group (those receiving a placebo, and those receiving 0.25% bupivacaine). |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 30/05/2003 |
| Date of final enrolment | 30/10/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Surgery
Bristol
BS16 1ND
United Kingdom
BS16 1ND
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
North Bristol NHS Trust (UK)
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 |
