Trial Comparing Intrathecal Morphine With Placebo In Patients Undergoing Robotic Cardiac Surgery

Completed · Phase 4 · Has a placebo group

Conditions studied: Pain

In brief

This is a randomized clinical trial in patients undergoing robotic myocardial revascularization with intraoperative extubation. Patients will be randomized into placebo or intrathecal morphine groups to assess postoperative pain scores and patient satisfaction. Patients will also be assessed for side effects from the intervention.

Key facts

Study ID

NCT03241485

Run by

University of Chicago

People needed

79

Starts

2018-06-19

Expected to finish

2020-09-01

Last updated by the study team

2021-11-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• patient undergoing elective robotic myocardial revascularization without anticipated use of cardiopulmonary bypass and with anticipated intraoperative tracheal extubation.

You may not qualify if…

• Emergency surgery
• Preoperative use of inotropes/IABP
• Preoperative use of opoids
• Ejection fraction less than 40%
• Anticipated use of cardiopulmonary bypass
• Previous cardiothoracic surgery
• Anticipated postoperative tracheal intubation
• severe pulmonary disease
• morbid obesity (BMI >35 kg/m2)
• severe hepatic impairment
• severe renal dysfunction (creatinine > 1.5)
• any contraindication to intrathecal injection (patient refusal, difficult patient anatomy, pre-existing coagulopathy, morphine allergy)

Where it is running

• University of Chicago Hospital — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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