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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03241485
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Drug: Intrathecal morphine Drug: Placebo Phase 4

Detailed Description:

Following Institutional Review Board approval and informed patient consent, 120 patients scheduled for elective robotic myocardial revascularization without cardiopulmonary bypass and anticipated intraoperative tracheal extubation will be studied. Patients will be randomized into one of two groups. Group A (placebo, control group) will receive intrathecal normal saline, Group B (morphine group) intrathecal morphine. All procedures will occur and administered medications given immediately prior to induction of general anesthesia in the operating room. Power analysis indicates that 60 patients per Group is appropriate, as further described below. Inclusion criteria include any patient undergoing elective robotic myocardial revascularization without anticipated use of cardiopulmonary bypass and with anticipated intraoperative tracheal extubation. Exclusion criteria include emergency surgery, ejection fraction less than 40%, preoperative use of inotropic agents or intraaortic balloon pump, anticipated use of cardiopulmonary bypass, previous cardiothoracic surgery, anticipated postoperative tracheal intubation, severe pulmonary disease, morbid obesity (BMI >35 kg/m2), severe renal dysfunction (creatinine > 1.5) recent history of opioid abuse, preoperative use of opioids, or any contraindication to intrathecal injection (patient refusal, difficult patient anatomy, pre-existing coagulopathy, morphine allergy).

Routine preoperative data will be collected (see Preoperative Data Sheet). Following intravenous access and routine mild sedation, each patient will be transported to the operating room and assume the sitting position. Following routine skin preparation, a routine lumbar intrathecal injection will be made via a 22-g spinal needle. The injectate will be either morphine (6 mcg/kg, maximum dose of 1 mg) or normal saline. The injectate will be prepared by a co-Investigator not directly involved in patient care. Thus, all preoperative, intraoperative, and postoperative caregivers will be blinded to intrathecal injectate composition (all injectates will be standardized to a total of 1.0 ml). All patients will have port incisions injected with 60 ml of 0.25% bupivacaine by the surgeon after the completion of surgery.

Following intrathecal injection, the patient will then assume the supine position. An arterial catheter will be inserted and general endotracheal anesthesia will be induced. Intraoperative anesthetic technique will be standardized and equivalent between Groups (see Intraoperative Anesthetic Protocol Sheet). The anesthetic protocol will allow tracheal extubation to occur in the operating room immediately after surgery (if clinically indicated).

Surgical technique will not be altered in any way. All patients in both Groups will be operated on by Husam H. Balky, MD. Routine intraoperative data will be collected (see Intraoperative Data Sheet). In all patients, tracheal extubation will be attempted in the operating room immediately after surgery (if clinically indicated).

Both Groups will receive routine postoperative care and identical postoperative analgesic protocols to assess adequacy of postoperative analgesia (see Postoperative Analgesia Protocol and Postoperative Data Sheets). A postoperative analgesic order set will be created specifically for study patients to receive IV acetaminophen every 6 hours for 24 hours. The American Pain Society Outcome Questionnaire (APS-POQ) will be administered to patients prior to discharge (see data sheet).15

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The patients will be randomized into 2 groups. The placebo group will receive intrathecal saline. The morphine group will receive intrathecal morphine.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All patients will receive intrathecal intervention and will not know which group they are assigned to. The provider performing the procedure and collecting the data will also be blinded to the intervention assignment.
Primary Purpose: Treatment
Official Title: Randomized, Double Blinded, Trial Comparing Intrathecal Morphine With Placebo in Patients Undergoing Robotic Totally Endoscopic Beating Heart Coronary Revascularization and Intraoperative Extubation
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
60 patients will be randomly assigned to this arm. The patients in this arm will receive intrathecal saline.
Drug: Placebo
Saline intrathecal given in the same manner as the intervention groups.

Active Comparator: Intrathecal morphine
60 patients will be randomly assigned to this arm. The patients in this arm will receive intrathecal morphine.
Drug: Intrathecal morphine
5 micrograms/kilogram of intrathecal morphine administered in the spinal space, not to exceed 1mg
Other Name: Duramorph




Primary Outcome Measures :
  1. Postoperative morphine consumption [ Time Frame: 24 hours after surgery ]
    We anticipate that patients in the intervention groups will require less postoperative morphine for pain control.


Secondary Outcome Measures :
  1. Pain Score [ Time Frame: First 48 hours after surgery ]
    Patients will score their pain on a visual analog scale of 0-10

  2. Patient Satisfaction [ Time Frame: 2-3 days after surgery, prior to discharge. ]
    Patients will take a satisfaction survey prior to discharge.

  3. Adverse effects [ Time Frame: Until discharge, 2-3 days after surgery ]
    adverse effects such as itching, nausea/vomiting, respiratory depression and sedation

  4. Cardiac arrhythmia/cardiac event [ Time Frame: 24 hours after surgery ]
    Postoperative EKG will be obtained in all patients.

  5. Pulmonary complication [ Time Frame: During hospital stay ]
    Pneumonia or reintubation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241485


Contacts
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Contact: Richa Dhawan, MD, MPH 312-437-0735 rdhawan@dacc.uchicago.edu
Contact: Mark Chaney, MD 773-702-1000 mchaney@dacc.uchicago.edu

Locations
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United States, Illinois
University of Chicago Hospital Recruiting
Chicago, Illinois, United States, 60637
Contact: Richa Dhawan, MD MPH    312-437-0735    rdhawan@dacc.uchicago.edu   
Contact: Mark Chaney, MD    773-702-1000    mchaney@dacc.uchicago.edu   
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Richa Dhawan, MD, MPH University of Chicago Hospital
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03241485    
Other Study ID Numbers: IRB17-1103
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents