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

NCT03241485 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB17-1103
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative Morphine Consumption

  We anticipate that patients in the intervention groups will require less postoperative morphine for pain control.

  24 hours after surgery

Secondary Outcomes (4)

• Pain Score

  First 48 hours after surgery

• Patient Satisfaction

  1-3 days after surgery, prior to discharge.

• Number of Participants With Nausea

  Until discharge, 2-3 days after surgery

• Number of Participants With Respiratory Depression

  During hospital stay

Study Arms (2)

Placebo

PLACEBO COMPARATOR

60 patients will be randomly assigned to this arm. The patients in this arm will receive intrathecal saline.

Drug: Placebo

Intrathecal morphine

ACTIVE COMPARATOR

60 patients will be randomly assigned to this arm. The patients in this arm will receive intrathecal morphine.

Drug: Intrathecal morphine

Interventions

Intrathecal morphine DRUG

5 micrograms/kilogram of intrathecal morphine administered in the spinal space, not to exceed 1mg

Also known as: Duramorph

Intrathecal morphine

Placebo DRUG

Saline intrathecal given in the same manner as the intervention groups.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Hospital

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Richa Dhawan
• Organization: University of Chicago Medicine

rdhawan@dacc.uchicago.edu

773-702-1000

Study Officials

• Richa Dhawan, MD, MPH

  University of Chicago Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients will be randomized into 2 groups. The placebo group will receive intrathecal saline. The morphine group will receive intrathecal morphine.

Study Record Dates

• First Submitted: May 20, 2017
• First Posted: August 7, 2017
• Study Start: June 19, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 23, 2021
• Results First Posted: November 23, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)