Intraoperative Methadone for Postoperative Pain Control After Thoracic Surgery

NCT04525898 | Terminated Phase 4 FDA Drug

• 1 other identifier: EH19-031
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Pain following surgery continues to be an important adverse outcome that may impact postoperative recovery. Opioids like fentanyl and hydromorphone are the primary medications used to provide analgesia, but paradoxically, may actually worsen pain when administered in the operating room. Methadone is a unique opioid which has N-methyl-D-aspartate (NMDA) receptor blocking properties, which may prevent the development of opioid-induced tolerance and hyperalgesia (increased sensitivity to pain induced by a drug). Studies have demonstrated that methadone reduces the need for analgesic medications and decreases pain after surgery. Furthermore, the addition of methadone to a standard anesthetic has been demonstrated to increase patient satisfaction with pain management and reduce the need for opioid analgesic medications during the first month after surgery. Some investigators have described methadone as a "opioid-sparing opioid" and recommended its use as part of a multimodal pain management strategy. There is a growing interest in reducing the use of traditional opioids in the operating room. The aim of this clinical trial is to compare pain scores and analgesic requirements in two groups of patients; one group will be randomized to receive a small dose of methadone at the start of surgery. The other group will be randomized to receive an equal volume of saline (salt water-control group) at the start of surgery. We hypothesize that patients randomized to be administered methadone at the start of surgery will have less postoperative pain and may require lower doses of pain medications than those given saline-control..

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Pain Scores

  Pain scores 24 hours after the surgical procedure

  24 hours after thoracic surgery

Secondary Outcomes (10)

• Pain Scores

  2 hours after thoracic surgery

• Pain Scores

  6 hours after thoracic surgery

• Pain Scores

  48 hours after thoracic surgery

• Pain Scores

  72 hours after thoracic surgery

• Analgesic requirements

  At 24 hours

Study Arms (2)

Methadone Group

ACTIVE COMPARATOR

The methadone group will receive a dose of methadone at induction of anesthesia (0.15 mg/kg ideal body weight (IBW)

Drug: Methadone

Control Group

PLACEBO COMPARATOR

The control group will be administered an equal volume of saline in an identical appearing syringe.

Drug: Methadone

Interventions

Methadone DRUG

The methadone group will receive an intravenous dose of methadone at induction of anesthesia (0.15 mg/kg ideal body weight (IBW)

Control Group; Methadone Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing any thoracoscopic procedure under general anesthesia

You may not qualify if:

• American Society of Anesthesiologists Physical Status 4 or 5, active heart failure, significant liver disease, previous adverse reactions to methadone, preoperative recent history of opioid or alcohol abuse, renal failure, or inability to comprehend the English language

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Methadone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Glenn S Murphy, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The hospital pharmacy will prepare two identical-appearing syringes; one will contain methadone and the other saline. The patients, care providers, and researchers will all be blinded to group assignment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group of patients will be randomized to receive a dose of methadone at induction of anesthesia (0.15 mg/kg ideal body weight (IBW)-methadone group)). The other group will be randomized to be administered an equal volume of saline in an identical appearing syringe (control group)

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: August 25, 2020
• Study Start: October 9, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: December 21, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)