Back to resultsMethadone in Ambulatory Surgery
Primary Purpose
Post-operative Pain, Anesthesia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
methadone
Control (Intra-operative administration of opioids, other than methadone)
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Pain focused on measuring fentanyl, morphine, methadone
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
Sites / Locations
- Barnes-Jewish Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Control
Treatment methadone 0.1 mg/kg
Treatment methadone 0.15 mg/kg
Arm Description
Control (Intra-operative administration of opioids, other than methadone)
methadone 0.1 mg/kg
Outcomes
Primary Outcome Measures
Intraoperative Opioid Administration
Data on opioids administered intraoperatively will be collected from the subject's EMR.
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]
Secondary Outcome Measures
Opioid Consumption Within First 30 Postoperative Days
Daily opioid consumption for approx 30 days following surgery (from hospital discharge until postop clinic visit).
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.
Full Information
NCT ID
NCT02300077
First Posted
November 18, 2014
Last Updated
May 14, 2019
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02300077
Brief Title
Methadone in Ambulatory Surgery
Official Title
Methadone in Ambulatory Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
February 12, 2018 (Actual)
Study Completion Date
February 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain, Anesthesia
Keywords
fentanyl, morphine, methadone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control (Intra-operative administration of opioids, other than methadone)
Arm Title
Treatment methadone 0.1 mg/kg
Arm Type
Active Comparator
Arm Description
methadone 0.1 mg/kg
Arm Title
Treatment methadone 0.15 mg/kg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
methadone
Other Intervention Name(s)
Dolophine
Intervention Description
Escalating dose of methadone up to .3mg/kg.
Intervention Type
Drug
Intervention Name(s)
Control (Intra-operative administration of opioids, other than methadone)
Other Intervention Name(s)
morphine fentanyl
Intervention Description
Intra-operative administration of opioids, other than methadone
Primary Outcome Measure Information:
Title
Intraoperative Opioid Administration
Description
Data on opioids administered intraoperatively will be collected from the subject's EMR.
Time Frame
Administered at induction of anesthesia
Title
Postoperative Opioid Administration
Description
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 Outcome Measure Information:
Title
Opioid Consumption Within First 30 Postoperative Days
Description
Daily opioid consumption for approx 30 days following surgery (from hospital discharge until postop clinic visit).
Time Frame
30 days
Title
Pain Relief Within First 30 Postoperative Days
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helga Komen, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29847382
Citation
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.
Results Reference
derived
Learn more about this trial
Methadone in Ambulatory Surgery
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