Condition category
Signs and Symptoms
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
25/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr A R Dixon

ORCID ID

Contact details

Department of Surgery
North Bristol NHS Trust
Frenchay Hospital
Frenchay
Bristol
BS16 1ND
United Kingdom
+44 (0)117 970 1212
anthony.dixon@north-bristol.swest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0234126586

Study information

Scientific title

Effects of subfascial infiltration of 0.25% bupivacaine versus N/saline in elective abdominal surgery: a randomised controlled trial.

Acronym

Study hypothesis

The effects of subfascial infiltration of 0.25% bupivacaine versus N/saline in elective abdominal surgery: a randomised controlled trial.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Surgery pain scores.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

30/05/2003

Overall trial end date

30/10/2003

Reason abandoned

Lack of staff

Eligibility

Participant 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).

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

30/05/2003

Recruitment end date

30/10/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Surgery
Bristol
BS16 1ND
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

North Bristol NHS Trust (UK)

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