Prevention of shoulder tip pain after right hemihepatectomy

ISRCTN	ISRCTN41856115
DOI	https://doi.org/10.1186/ISRCTN41856115
Protocol serial number	N0025128440
Sponsor	Department of Health
Funder	Aintree Hospitals 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

Dr M Hawkins
Scientific

Anaesthesia
University Hospital Aintree
Longmoor Lane
Fazakerley
Liverpool
L9 7AL
United Kingdom

Phone	+44 (0)151 529 5152
Email	abc@email.com

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Prevention of shoulder tip pain after right hemihepatectomy
Study objectives	To assess whether infiltration of the diaphragm with local anaesthetic will prevent shoulder tip pain after hemihepatectomy
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/02/2006

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	40
Key inclusion criteria	40 adult patients
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/2003
Date of final enrolment	01/02/2006

University Hospital Aintree

Liverpool
L9 7AL
United Kingdom

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