Post-Laparoscopic Cholecystectomy Pain: Benefit of Intraperitoneal Saline

ISRCTN	ISRCTN63839707
DOI	https://doi.org/10.1186/ISRCTN63839707
Protocol serial number	N0533152392
Sponsor	Department of Health
Funder	Queen Mary's Sidcup NHS Trust (UK)

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

Mr Daniel Thomas
Scientific

Queen Mary's Sidcup NHS Trust
Sidcup
DA14 6LT
United Kingdom

Phone	+44 20 8302 2678
Email	daniel.thomas@qms.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Post-Laparoscopic Cholecystectomy Pain: Benefit of Intraperitoneal Saline
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Signs and Symptoms: Post operative pain
Intervention	1. Normal saline instilled intraperitoneally at end of operation 2. Control
Intervention type	Other
Primary outcome measure(s)	1. Pain Score 2. Nausea 3. Vomiting 4. Duration of hospitalisation 5. Re-admission within 10 days
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/09/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	80
Key inclusion criteria	80 patients at Queen Mary's
Key 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
Date of first enrolment	01/10/2004
Date of final enrolment	30/09/2005

Queen Mary's Sidcup NHS Trust

Sidcup
DA14 6LT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

09/09/2016: No publications found in PubMed, verifying study status with principal investigator.