Condition category
Signs and Symptoms
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
18/11/2016
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

Dr David Patrick

ORCID ID

Contact details

Anaesthetic Department Arrowe Park Hospital
Wirral Hospital NHS Trust
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom
+44 151 678 5111 ext 2334
dpatrick@doctors.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0280156550

Study information

Scientific title

Intraperitoneal levobupivacaine and dexamethasone for post-operative pain after laparoscopic cholecystectomy

Acronym

Study hypothesis

Intraperitoneal levobupivacaine and dexamethasone for Post-operative pain after laparoscopic cholecystectomy

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

Treatment

Patient information sheet

Condition

Signs and Symptoms: Post operative pain

Intervention

Randomised Controlled Trial. 3 groups:
1. Control group will not receive intraperitoneal local anaesthetic or dexamethasone as is our usual practice
2. L group will receive 15 ml of 0,5% levobupivacaine after establishing pneumoperitoneum and again at the end of the procedure
3. LD group as group L plus dexamethasone

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Pain Scores

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2004

Overall trial end date

01/07/2006

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

Patients undergoing Laparoscopic Cholecystectomy

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

90 patients, 30 in each group

Participant exclusion criteria

1. Patients allergic to local anaesthetics or dexamethasone, ASA IV and V patients.
2. Patients with acute cholecystitis
3. Patients with previous laparotomy, any intraoperative complications like perforation of the gall bladder, major vascular injury and any procedure which is converted to an open one

Recruitment start date

01/10/2004

Recruitment end date

01/07/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Anaesthetic Department Arrowe Park Hospital
Wirral
CH49 5PE
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

Wirral Hospitals NHS Trust (UK) - NHS R&D Support Funding

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

18/11/2016: This trial was stopped due to a recruitment issue. 12/08/2016: No publications found in PubMed, verifying study status with principal investigator.