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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list