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

ISRCTN	ISRCTN80508655
DOI	https://doi.org/10.1186/ISRCTN80508655
Secondary identifying numbers	N0280156550

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 18/11/2016

Recruitment status: Stopped
Overall study status: Stopped
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

Dr David Patrick
Scientific

Anaesthetic Department Arrowe Park Hospital
Wirral Hospital NHS Trust
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom

Phone	+44 151 678 5111 ext 2334
Email	dpatrick@doctors.org.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Intraperitoneal levobupivacaine and dexamethasone for post-operative pain after laparoscopic cholecystectomy
Study objectives	Intraperitoneal levobupivacaine and dexamethasone for Post-operative pain after laparoscopic cholecystectomy
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Pain Scores
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/10/2004
Completion date	01/07/2006
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	90 patients, 30 in each group
Key inclusion criteria	Patients undergoing Laparoscopic Cholecystectomy
Key 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
Date of first enrolment	01/10/2004
Date of final enrolment	01/07/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Anaesthetic Department Arrowe Park Hospital

Wirral
CH49 5PE
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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.