Prospective randomized trial to assess the efficacy of 0.5% Marcaine subserosal injection in the gall bladder fossa to reduce the post operative pain from laparoscopic cholecystectomy

ISRCTN	ISRCTN68753145
DOI	https://doi.org/10.1186/ISRCTN68753145
Secondary identifying numbers	N0008171900

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 06/09/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Mr Amir Nisar
Scientific

Portsmouth Road
Camberley
Camberley
GU16 7UJ
United Kingdom

Phone	+44 (0)7859888713
Email	dranisar@yahoo.co.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
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Prospective randomized trial to assess the efficacy of 0.5% Marcaine subserosal injection in the gall bladder fossa to reduce the post operative pain from laparoscopic cholecystectomy
Study hypothesis	Pain after Laparoscopic Cholecystectomy (key hole removal of gall bladder) is much lower than an open operation for the removal of gall bladder. However one can still expect mild to moderate pain after the key hole operation. Can we reduce the post operative pain after the key hole operation by injecting local anaesthetic in the gall bladder bed?
Ethics approval(s)	Not provided at time of registration
Condition	Signs and Symptoms: Pain
Intervention	We will recruit every suitable patient who undergoes a Laparoscopic Cholecystectomy under either of the Upper Gastrointestinal Surgeons at Frimley Park Hospital. They will be given information leaflet about Laparoscopic cholecystectomy, and also given a leaflet with a diagram showing the site of injection. An informed consent will be taken for the study in addition to the standard consent form for the procedure. The surgeon will be unaware of the nature of the solution that he will inject into the gall bladder fossa (saline and bupivicaine injection will be shown to him pre op to check their details). A member of the team will draw an envelope to randomize the patients in either arm and will brief the nurse about the injection without the surgeon becoming aware of this Solution will be carefully injected with a 0.2 mm epidural needle connected to a syringe percutaneously in the subserosal area taking great care not to inject intravascularly. The rest of the operation will be performed as normal. Pain levels will be assessed at various periods after the operation and the results will be compared.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Marcaine
Primary outcome measure	Post operative pain scores
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/08/2005
Overall study end date	01/01/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	We plan to recruit approximately 25 patients in each arm
Participant inclusion criteria	Not provided at time of registration
Participant exclusion criteria	Not provided at time of registration
Recruitment start date	01/08/2005
Recruitment end date	01/01/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Portsmouth Road

Camberley
GU16 7UJ
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health
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

Frimley Park Hospital NHS Foundation Trust (UK)

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

06/09/2016: No publications found, verifying study status with principal investigator.