Methadone in Ambulatory Surgery

The μ-opioid receptor agonist methadone is frequently used in adult anesthesia and adult pain therapy. Methadone has an extremely long half-life, which confers therapeutic advantage by providing more stable plasma concentrations and long-lasting pain relief. Methadone perioperative pharmacokinetics and effectiveness in perioperative pain relief in inpatients is well characterized. There is, however, no information on methadone use in an ambulatory surgery setting and outpatient procedures. This pilot investigation will determine effectiveness of intraoperative methadone in reducing postoperative opioid consumption and providing improved pain relief in patients undergoing moderately painful, ambulatory surgical procedures.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Post-operative Pain
• Intervention / Treatment: Drug: Control (Intra-operative administration of opioids, other than methadone); Drug: methadone

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-65 years
• Undergoing general anesthesia and moderately painful, ambulatory surgical procedures with anticipated overnight, postop hospital stay of < 24 hours
• Signed, written, informed consent

Exclusion Criteria:

• History of or known liver or kidney disease.
• Females who are pregnant or nursing.
• Opioid tolerant patients (e.g. preoperative methadone therapy or use of fentanyl transdermal patches)
• History of allergy to methadone

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Control (Intra-operative administration of opioids, other than methadone)	Drug: Control (Intra-operative administration of opioids, other than methadone); Intra-operative administration of opioids, other than methadone; Other Names: morphine fentanyl
Active Comparator: Treatment methadone 0.1 mg/kg; methadone 0.1 mg/kg	Drug: methadone; Escalating dose of methadone up to .3mg/kg.; Other Names: Dolophine
Active Comparator: Treatment methadone 0.15 mg/kg	Drug: methadone; Escalating dose of methadone up to .3mg/kg.; Other Names: Dolophine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Opioid Administration	Data on opioids administered intraoperatively will be collected from the subject's EMR.	Administered at induction of anesthesia
Postoperative Opioid Administration	Data on opioids administered postoperatively will be collected from the subject's EMR. Pain severity will be assessed using Numeric Rating Scale and colored-visual analogue scale. Pain relief postoperatively will be assessed using a 5 point scale [0-no relief, 4-complete relief]	EMR reviewed at 24 hours post-administration or at hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption Within First 30 Postoperative Days	Daily opioid consumption for approx 30 days following surgery (from hospital discharge until postop clinic visit).	30 days
Pain Relief Within First 30 Postoperative Days	Daily pain self-assessments using a numeric (0-10) rating scale were recorded in a home diary for approx 30 days following surgery (from hospital discharge until postop clinic visit). Zero was no pain and 10 was the worst possible pain. Patient's 30-day post-discharge scores were averaged individually and compared in between groups. In addition, participants recorded pain interference with 7 activities of daily living - mood, ability to walk or move, sleep, normal work outside the home, normal work at home, recreational activities, and enjoyment of life on a 5-point Likert scale. Questions were based on the Patient-Reported Outcomes Measurement Information System Pain Behavior and Pain Interference item banks. Patients also recorded opioid and nonopioid analgesic use, sedation, and time to return to work.	30 days

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Helga Komen, MD, Washington University School of Medicine

Publications and helpful links

General Publications

• Komen H, Brunt LM, Deych E, Blood J, Kharasch ED. Intraoperative Methadone in Same-Day Ambulatory Surgery: A Randomized, Double-Blinded, Dose-Finding Pilot Study. Anesth Analg. 2019 Apr;128(4):802-810. doi: 10.1213/ANE.0000000000003464.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): February 12, 2018
• Study Completion (Actual): February 12, 2018

Study Registration Dates

• First Submitted: November 18, 2014
• First Submitted That Met QC Criteria: November 21, 2014
• First Posted (Estimate): November 24, 2014

Study Record Updates

• Last Update Posted (Actual): May 17, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: methadone; fentanyl, morphine
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Respiratory System Agents; Antitussive Agents; Fentanyl; Morphine; Methadone
• Other Study ID Numbers: 201408002

Plan for Individual participant data (IPD)

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