Condition category
Signs and Symptoms
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
06/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Amir Nisar

ORCID ID

Contact details

Portsmouth Road
Camberley
Camberley
GU16 7UJ
United Kingdom
+44 (0)7859888713
dranisar@yahoo.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0008171900

Study information

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

Acronym

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

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

Not available in web format, please use contact details to request a participant information sheet

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

Phase

Not Applicable

Drug names

Marcaine

Primary outcome measures

Post operative pain scores

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2005

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

We plan to recruit approximately 25 patients in each arm

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

United Kingdom

Trial participating centre

Portsmouth Road
Camberley
GU16 7UJ
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Frimley Park Hospital NHS Foundation 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

Publication citations

Additional files

Editorial Notes

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