The Effect of Choice of Intraoperative Opioid on Postoperative Pain

NCT01542645 | Completed Phase 4 Results

• 1 other identifier: ENH10-256
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this randomized, double-blind study is to examine the effect of a single intraoperative dose of methadone on postoperative pain and analgesic requirements in patients undergoing cardiac surgery with cardiopulmonary bypass. These patients will be compared to subjects receiving a standard dose of the "traditional" intraoperative opioid (fentanyl). Secondary outcome measures to be assessed will include standard recovery variables (such as length of postoperative intubation, ICU length of stay, incidence of nausea or vomiting, level of sedation). In addition, patients will be assessed for the development of chronic postoperative pain.

Conditions

Pain, Postoperative; Chronic Pain

Keywords

Fentanyl; Methadone; Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• Total Opioid Consumption in the Postoperative Period

  Total intravenous morphine used first three days (72 hours after ICU admission)

  First 3 days after surgery

Secondary Outcomes (6)

• Postoperative Pain Scores

  2 hours after cardiac surgery

• Chronic Postoperative Pain Scores-Weekly Frequency of Pain

  1 months after surgery

• Marker of Myocardial Injury (Troponin I)

  12 hours after surgery

• 3 Months-Chronic Pain-weekly Frequency of Pain

  3 months

• 6 Months-Chronic Pain-weekly Frequency of Pain

  6 months

Study Arms (2)

Methadone

EXPERIMENTAL

Long-acting opioid

Drug: Methadone

Fentanyl

ACTIVE COMPARATOR

Shorter-acting opioid

Drug: Fentanyl

Interventions

Methadone DRUG

Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.

Also known as: opioid

Methadone

Fentanyl DRUG

Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.

Also known as: opioid

Fentanyl

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
• Significant hepatic dysfunction (liver function tests \> 2 times upper normal limit)
• Preoperative ejection fraction \< 30%
• Pulmonary disease necessitating home oxygen therapy
• Preoperative requirement for inotropic agents or intraaortic balloon pump to maintain hemodynamic stability
• Allergy to methadone or fentanyl
• Preoperative pain, use of preoperative opioids, or recent history of opioid abuse

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain

Interventions

Methadone; Analgesics, Opioid; Fentanyl

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Glenn Murphy, MD
• Organization: NorthShore University HealthSystem

dgmurphy2@yahoo.com

847-570-2760

Study Officials

• Glenn S. Murphy, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiac Anesthesia and clinical Research

Study Record Dates

• First Submitted: February 26, 2012
• First Posted: March 2, 2012
• Study Start: September 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: September 1, 2014
• Last Updated: September 30, 2019
• Results First Posted: May 26, 2014

Record last verified: 2019-09

Locations

US (1)