Does continuous rectal sheath block decrease postoperative opioid requirement?

ISRCTN ISRCTN46452718
DOI https://doi.org/10.1186/ISRCTN46452718
Secondary identifying numbers N0283122688
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
16/01/2014
Recruitment status
No longer recruiting
Overall study status
Completed
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 William Woods
Scientific

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

Study information

Study designSingle centre prospective randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesDoes 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSigns and Symptoms: Pain, nausea, vomiting, itching
Intervention1. 0.25% Bupivacaine
2. Saline
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)bupivacaine
Primary outcome measureThe 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 measuresSecondary 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 study start date20/04/2002
Completion date20/06/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants40
Key inclusion criteria40 consenting patients due to undergo a laparotomy.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment20/04/2002
Date of final enrolment20/06/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Industry

Commercial educational grant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan