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

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Signs and Symptoms: Post operative pain
Primary Contact Details
Not Recruiting
Recruitment Status
ISRCTN55888454
Primary Trial ID Number
Summary
Not provided at time of registration
Research Details
  • 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?
Phase
Not Specified
Study Design
Randomised controlled trial
Study Type
Interventional
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
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
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
Gender
Not Specified
Age Range
Not Specified
Who Can Participate
Patient
Number of Participants
Not provided at time of registration
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
Trial Location(s)
Birmingham
B15 2TH
Trial Contact(s)
Primary Trial Contact
Dr D Green
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
Sorry, this information is not available
EudraCT Number
Sorry, this information is not available
Funder(s)
  • University Hospital Birmingham NHS Trust (UK)
Other Study ID Numbers
N0265006248
Sponsor(s)
Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
Key Dates

Recruitment Start Date

01 Sep 2004

Recruitment End Date

01 Jan 2007

Trial Start Date

01 Sep 2004

Trial End Date

01 Jan 2007

Date Assigned

30 Sep 2005

Last Updated

13 Mar 2014