Methadone and Quality of Postoperative Recovery

NCT03168958 | Recruiting Phase 4 FDA Drug

• 1 other identifier: EH16-374
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing cardiac surgery often experience moderate to severe pain in the early postoperative period. A number of methods have been used to help control pain after surgery; however, each of these techniques adds additional costs and risks. A simple and effective way to decrease this pain is to administer a long-acting opioid in the operating room. Methadone is a opioid that can produce analgesia (pain relief) that lasts up to 48 hours when given in large doses (0.3 to 0.4 mg/kg). Previous studies have demonstrated that both pain and requirements for analgesic medications are significantly reduced for up to three days after surgery if methadone is given at induction (the start) of anesthesia. In the study that was performed at Evanston Hospital, cardiac surgical patients who were given methadone also appeared to "feel better" after surgery compared to those given a standard or typical intraoperative opioid. The aim of this randomized clinical trial is to determine whether overall quality of postoperative recovery can be enhanced if methadone is given in the operating room. Quality of recovery will be determined by using a validated scoring system, the QoR 40, which will be given to patients to complete on the first three days after surgery.

Conditions

Quality of Recovery Scores

Outcome Measures

Primary Outcomes (1)

• Quality of recovery scores (QoR 40) on postoperative day 1

  The QoR 40 scoring system will be used to assess postoperative quality of recovery

  24 hours

Secondary Outcomes (8)

• Quality of recovery scores (QoR 40) on postoperative day 2

  48 hours

• Quality of recovery scores (QoR 40) on postoperative day 3

  72 hours

• Pain scores on on postoperative day 1

  24 hours

• Pain scores on on postoperative day 1

  48 hours

• Analgesic requirements on postoperative day 1

  24 hours

Study Arms (2)

Methadone Group

ACTIVE COMPARATOR

Patients in this group will receive 0.4 mg/kg of methadone at induction of anesthesia

Drug: Methadone

Saline-Control Group

SHAM COMPARATOR

Patients in this group will receive an equal volume of saline as the active comparator group at induction of anesthesia

Drug: Saline

Interventions

Methadone DRUG

Methadone will be provided at induction of anesthesia

Methadone Group

Saline DRUG

Saline will be administered at induction of anesthesia

Saline-Control Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients presenting for elective cardiac surgery with CPB will be eligible for enrollment

You may not qualify if:

• Preoperative renal failure requiring dialysis or severe renal dysfunction (serum creatinine \> 2.0 mg/dL)
• Significant hepatic dysfunction (liver function tests \> 2 times upper normal limit)
• Pulmonary disease necessitating home oxygen therapy
• Preoperative requirement for inotropic agents or intraaortic balloon pump to maintain hemodynamic stability
• Allergy to methadone or fentanyl
• Significant preoperative pain requiring treatment with opioids or recent history of opioid abuse
• Inability to speak or read the English language or neurologic conditions that may impair the ability to complete the QoR 40 questionnaire.

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

RECRUITING

MeSH Terms

Interventions

Methadone; Sodium Chloride

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Glenn S Murphy, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Glenn S Murphy, MD

CONTACT

847-570-2760; dgmurphy2@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study drugs will be prepared by the operating room pharmacy. All patients and care providers will be blinded to group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Clinical Research

Model Details: Patients will be randomized to receieve either methadone or saline-control

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: May 30, 2017
• Study Start: December 25, 2018
• Primary Completion: May 25, 2021
• Study Completion: July 25, 2021
• Last Updated: August 24, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)