Condition category
Signs and Symptoms
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
08/04/2014
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 R Anderson

ORCID ID

Contact details

Surgical CSG
Ormskirk Dist Gen Hosp
Wigan Road
Ormskirk
L39 2AZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0650147577

Study information

Scientific title

Acronym

Study hypothesis

1. Does Pre-incisional injection of bupivacaine decrease postoperative pain following laparoscopic cholecystectomy and allow for early discharge from hospital?
2. To determine any early or late (6 week) related complications.

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Signs and Symptoms: Post operative pain

Intervention

Randomisation of patients to intervention group and control group.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Pain intensity scored using visual analogue scale at 4, 6 and 24 hrs from the commencement of operation
2. Time to first demand of analgesia
3. Total analgesic requirement in first 24 hrs
4. Assessment of opportunity for same day discharge
5. Assessment of early/late (6 weeks) postoperative complications
6. Scar quality at 6 weeks

Secondary outcome measures

Not provided at time of registration

Overall trial start date

17/01/2002

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

60 patients from waiting lists of two General Surgeons based at Ormskirk District General Hospital (RJL Anderson; NK Matar)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

17/01/2002

Recruitment end date

31/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Surgical CSG
Ormskirk
L39 2AZ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Southport and Ormskirk Hospital 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