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. | Not Recruiting
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.

Trial Source

Health Conditions
  • Signs and Symptoms: Post operative pain
Not Recruiting
Recruitment Status
ISRCTN55888454
Primary Trial ID Number
Summary
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?
Primary Outcome Measures
  • 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
Research Question
  • 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?
Design Type
Sorry, this information is not available
Ethics Approval
Not provided at time of registration
Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Not Specified
Participant Age Range
Not Specified
Participant Type
Patient
Trial Sample Size
0
Participant Inclusion Criteria
  • Patients with preserved myocardial function undergoing elective myocardial revascularisation having given written informed consent.
Participant Exclusion Criteria
  • Not provided at time of registration
Interventions
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
Design Details
Sorry, this information is not available
Study Design
Randomised controlled trial
Results Reporting
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Acronym
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Scientific Title
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Secondary Trial Identifying Number
N0265006248
Website
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Study Funded By
University Hospital Birmingham NHS Trust (UK)
Funder Type
Sorry, this information is not available
Study Sponsored By
Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment

01 Sep 2004

Recruitment End Date

01 Jan 2007

Trial End Date

01 Jan 2007

Date added to Registry

30 Sep 2005

Last Updated

13 Mar 2014