An assessment of the efficacy of intrathecal morphine followed by intra-operative remifentanil infusion in the control of early post-operative pain relief in coronary artery bypass surgery.

ISRCTN	ISRCTN55888454
DOI	https://doi.org/10.1186/ISRCTN55888454
Secondary identifying numbers	N0265006248

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 13/03/2014

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 of protocol

Not provided at time of registration

Contact information

Dr D Green
Scientific

Anaesthetics
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	The aim of this study is to compare the efficacy of intrathecal morphine and intravenous remifentanil against a standard analgesic technique in patients undergoing elective myocardial revascularisation. There are two main questions that it aims to answer: 1. Does this method provide a smooth, reliable, and pain-free recovery after surgery? 2. Is there any difference in pain control, recovery characteristics (e.g. time to resumption of spontaneous respiration, time to reach extubation criteria), or side effect profile?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Signs and Symptoms: Post operative pain
Intervention	Each volunteer will be randomly allocated (using random number tables) to one of two groups: 1. Intrathecal morphine/Remifentanil group 2. Fentanyl/Alfentanil (control) group After transfer to the ITU the volunteer will remain sedated until they are haemodynamically stable, have a body temperature above 35 degrees Celsius, and are not excessively bleeding. At this point the sedative agent will be stopped and the volunteer will be extubated after specific extubation criteria have been met. Data will be collected for the pre-, intra-, and post-operative periods. One of the investigators will remain with the volunteer from the time of ITU admission to the end of the study period. He/she will be responsible for all data collection and will oversee the analgesic management. The volunteer may request to withdraw from the study at any time. The investigator will withdraw the volunteer from the study if: 1. A critical incident occurs 2. There are peri-operative complications e.g. myocardial dysfunction requiring inotropic support 3. There is excessive post-operative bleeding
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	intrathecal morphine, intravenous remifentanil
Primary outcome measure	To compare the efficacy of intrathecal morphine and intravenous remifentanil against a standard analgesic technique in patients undergoing elective myocardial revascularisation.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/09/2004
Completion date	01/01/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	Patients with preserved myocardial function undergoing elective myocardial revascularisation having given written informed consent.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/09/2004
Date of final enrolment	01/01/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Anaesthetics

Birmingham
B15 2TH
United Kingdom

Sponsor information

Department of Health
Government

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

University Hospital Birmingham NHS 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