Contact information
Type
Scientific
Primary contact
Mr Daniel Thomas
ORCID ID
Contact details
Queen Mary's Sidcup NHS Trust
Sidcup
DA14 6LT
United Kingdom
+44 20 8302 2678
daniel.thomas@qms.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0533152392
Study information
Scientific title
Post-Laparoscopic Cholecystectomy Pain: Benefit of Intraperitoneal Saline
Acronym
Study hypothesis
Study aims:
1. To assess a simple way of pain reduction post-operatively
2. To evaluate if this intervention influences the timing of patient discharge and the rate of day case Laparoscopic Cholecystectomy
3. To examine individual differences and identify patient characteristics that may predict likely success and failure from this intervention
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
1. Normal saline instilled intraperitoneally at end of operation
2. Control
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Pain Score
2. Nausea
3. Vomiting
4. Duration of hospitalisation
5. Re-admission within 10 days
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2004
Overall trial end date
30/09/2005
Reason abandoned
Eligibility
Participant inclusion criteria
80 patients at Queen Mary's
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
80
Participant exclusion criteria
1. Any procedure which had to be converted to laparotomy
2. Any patient where the operating surgeon did not adhere to the study protocol
3. Any patient whose cognitive function does not allow them to understand consent to this study
Recruitment start date
01/10/2004
Recruitment end date
30/09/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen Mary's Sidcup NHS Trust
Sidcup
DA14 6LT
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Queen Mary's Sidcup 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