Condition category
Signs and Symptoms
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/01/2014
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

Mr William Woods

ORCID ID

Contact details

Worthing & Southlands Hospitals NHS Trust
Worthing Hospital
Lyndhurst Road
Worthing
West Sussex
BN11 2DH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0283122688

Study information

Scientific title

Acronym

Study hypothesis

Does the intermittent infiltration of 0.25% bupivacaine delivered by an epidural catheter into the rectus sheath decrease the opioid requirement postoperatively after a midline laparotomy?

Ethics approval

Not provided at time of registration

Study design

Single centre prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Signs and Symptoms: Pain, nausea, vomiting, itching

Intervention

1. 0.25% Bupivacaine
2. Saline

Intervention type

Drug

Phase

Not Specified

Drug names

bupivacaine

Primary outcome measures

The primary outcome measure will be the total amount of opiate used in the intravenous patient controlled analgesia (IVPCA) in the first 48 h.
.

Secondary outcome measures

Secondary outcome measures will be forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) at 24 and 48 h, the number of episodes of nausea, vomiting, itching, the sedation score, and respiratory rate, the time to passage of flatus and the length of hospital stay.

Overall trial start date

20/04/2002

Overall trial end date

20/06/2004

Reason abandoned

Eligibility

Participant inclusion criteria

40 consenting patients due to undergo a laparotomy.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

20/04/2002

Recruitment end date

20/06/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Worthing & Southlands Hospitals NHS Trust
Worthing, West Sussex
BN11 2DH
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Industry

Funder name

Commercial educational grant

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