Methadone in Ambulatory Surgery

Washington University School of Medicine60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Post-operative Pain Anesthesia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Intraoperative Opioid Administration

Data on opioids administered intraoperatively will be collected from the subject's EMR.

Time frame: 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 \[0-no relief, 4-complete relief\]

Time frame: EMR reviewed at 24 hours post-administration or at hospital discharge

Secondary Outcomes

Opioid Consumption Within First 30 Postoperative Days

Daily opioid consumption for approx 30 days following surgery (from hospital discharge until postop clinic visit).

Time frame: 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.