Condition category
Signs and Symptoms
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
05/12/2014
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

Dr M Hawkins

ORCID ID

Contact details

Anaesthesia
University Hospital Aintree
Longmoor Lane
Fazakerley
Liverpool
L9 7AL
United Kingdom
+44 (0)151 529 5152
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0025128440

Study information

Scientific title

Prevention of shoulder tip pain after right hemihepatectomy

Acronym

Study hypothesis

To assess whether infiltration of the diaphragm with local anaesthetic will prevent shoulder tip pain after hemihepatectomy

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

At end of proposed surgery prior to closure of abdomen, the diaphragm will be infiltrated with 20 ml of solution consisting of either 0.25% bupivicaine or 0.9% saline by the surgeon. Solutions will be made up in Pharmacy and delivered in sterile syringes such that neither surgeon nor anaesthetist will know what has been administered. Closure of abdomen and recovery from anaesthesia will proceed in normal way and patient will be moved to recovery area. When recovered they will be assessed for presence/absence of shoulder-tip and/or abdominal pain. (If abdominal pain is present, epidural will be topped up in usual manner). If shoulder-tip pain is present attempts will be made to rate this as mild, moderate or severe. Rescue analgesia will be with ketorolac as is current practice.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2003

Overall trial end date

01/02/2006

Reason abandoned

Eligibility

Participant inclusion criteria

40 adult patients

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/2003

Recruitment end date

01/02/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital Aintree
Liverpool
L9 7AL
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

Aintree Hospitals 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

Publication citations

Additional files

Editorial Notes