Methadone in Ambulatory Surgery

Anesthesia Clinical Trial

Official title:

Methadone in Ambulatory Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300077
• Other study ID #: 201408002
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: February 12, 2018

Study information

• Verified date: May 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 12, 2018
• Est. primary completion date: February 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Pain, Postoperative
• Post-operative Pain

Intervention

Drug:
• methadone
Escalating dose of methadone up to .3mg/kg.
• Control (Intra-operative administration of opioids, other than methadone)
Intra-operative administration of opioids, other than methadone

Locations

Country	Name	City	State
United States	Barnes-Jewish Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative Opioid Administration	Data on opioids administered intraoperatively will be collected from the subject's EMR.	Administered at induction of anesthesia
Primary	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	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
Secondary	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