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

Randomized, Double Blinded, Trial Comparing Intrathecal Morphine With Placebo in Patients Undergoing Robotic Totally Endoscopic Beating Heart Coronary Revascularization and Intraoperative Extubation

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Placebo; Drug: Intrathecal morphine

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 (5 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 the same surgeon. 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). The American Pain Society Outcome Questionnaire (APS-POQ) will be administered to patients prior to discharge (see data sheet).15

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Duramorph

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Morphine Consumption	We anticipate that patients in the intervention groups will require less postoperative morphine for pain control.	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	Patients will score their pain on a visual analog scale of 0-10. The higher the score, the worse the patients reported pain is at that time .	First 48 hours after surgery
Patient Satisfaction	Patients will take a satisfaction survey prior to discharge, this is measured by calculating a score on a scale. This survey consist of questions that asks about the subjects post-operative experience with pain. Higher reported scores represent worse post-operative subject experience. These are ranked from a 0-10 scale, where 0 is the best experience and 10 meaning the worst experience. Questions being asked how satisfied they were with the results of the pain treatment while hospitalized, least pain in prior 24 hours, worst pain in prior 24 ours, percent time in severe pain, how much pain interfered with different activities, how much pain caused anxiety, depression, fright, helplessness, how severe were symptoms of nausea, drowsiness, itching, dizziness, and percentage pain relief in prior 24 hours.	1-3 days after surgery, prior to discharge.
Number of Participants With Nausea	Daily evaluation of nausea post-operatively throughout the subjects hospital stay.	Until discharge, 2-3 days after surgery
Number of Participants With Respiratory Depression	Opioid related respiratory depression, post-operatively throughout the subjects hospital stay.	During hospital stay

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Richa Dhawan, MD, MPH, University of Chicago Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2018
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: May 20, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: IRB17-1103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No