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Completed

NCT Number: NCT02300077

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.

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Key information

Conditions

Post-operative Pain Anesthesia Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methadone

Drug

Escalating dose of methadone up to .3mg/kg.

Other names: Dolophine

Control (Intra-operative administration of opioids, other than methadone)

Drug

Intra-operative administration of opioids, other than methadone

Other names: morphine fentanyl

Primary outcomes

  1. Intraoperative Opioid Administration

    Time frame: Administered at induction of anesthesia

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

  2. Postoperative Opioid Administration

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

    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]

Secondary outcomes

  1. Opioid Consumption Within First 30 Postoperative Days

    Time frame: 30 days

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

  2. Pain Relief Within First 30 Postoperative Days

    Time frame: 30 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Nov 24, 2014
Registry last updated
May 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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