Methadone in Ambulatory Surgery

ID: NCT02300077
Status: Recruiting
Phase: N/A
Start Date: December 01, 2014
First Submitted: November 18, 2014
Last Updated: February 08, 2018
Results: N/A
Sponsors & Collaborators: Washington University School of Medicine
Location: United States
Conditions: Post-operative Pain, Anesthesia
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Study Description

Brief Summary

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Anesthesia

Post-operative Pain

Drug: methadone
Other Names
Dolophine
Drug: Control (Intra-operative administration of opioids, other than methadone)
Other Names
morphine fentanyl
N/A

Tracking Information

First Submitted DateNovember 18, 2014
Last Update Posted DateFebruary 08, 2018
Actual Start DateDecember 01, 2014
Anticipated Completion DateDecember 01, 2019
Actual Primary Completion DateDecember 31, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Postoperative opioid administration [Time Frame: 24 hours]

    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]

  • Intraoperative opioid administration [Time Frame: 24 hours]

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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Opioid consumption and pain relief within first 30 postoperative days [Time Frame: 30 days]

    Daily opioid consumption and daily pain self-assessments using a colored-visual analogue scale will be recorded in a home diary for approx 30 days following surgery (from hospital discharge until postop clinic visit). Additional ORSDS assessments will be recorded at various timepoints (approx 7, 14 and 30 days postop) in the home diary.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleMethadone in Ambulatory Surgery
Official TitleMethadone in Ambulatory Surgery
Brief Summary

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.

Detailed Description

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
60
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
Primary Purpose
Treatment
Conditions
Anesthesia
Post-operative Pain
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: methadone

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

Other Names
Dolophine
Drug: Control (Intra-operative administration of opioids, other than methadone)

Intra-operative administration of opioids, other than methadone

Other Names
morphine fentanyl
Study Groups/Cohorts
Control
Control (Intra-operative administration of opioids, other than methadone)

Treatment
methadone

Study Arms
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

Active Comparator Treatment
methadone
Drug : methadone
Escalating dose of methadone up to .3mg/kg.

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)
Active Comparator Treatment
methadone
Drug : methadone

Recruitment Information

Recruitment Status:Recruiting
Enrollment60
Completion DateDecember 01, 2019
Eligibility Criteria: 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
GenderAll
Age18 Years to 65 Years
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02300077
Other Study ID Numbers
201408002
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Washington University School of Medicine
Collaborators
Not Available
Investigators
Principal Investigator
Helga Komen, MD
Washington University School of Medicine