Clinical trial NCT05693675: Postoperative Oral Methadone After Major Spine Surgery; Safety, Feasibility and Efficacy in Prevention of Progression to Chronic Opioid Usage at 3 Months
Official title: Postoperative Oral Methadone After Major Spine Surgery; Safety, Feasibility and Efficacy in Prevention of Progression to Chronic Opioid Usage at 3 Months - A Pilot Trial.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Spine Surgery
Keywords: opioids
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the feasibility and safety of a clinical protocol based on the administration of intraoperative intravenous methadone followed by a short regimen of oral/IV (if the patient is not able to take oral) methadone following spine surgery and to evaluate if methadone decreases persistent opioid usage at 3 months in comparison to placebo.


Eligibility criteria: Inclusion Criteria:

* Adults undergoing multilevel complex lumbar and/or thoracic spine fusion surgery, including revision surgeries

Exclusion Criteria:

* BMI greater than 40

Primary outcomes:
measure: Feasibility of study design as assessed by the number of participants for which scheduled postoperative methadone versus placebo were able to be administered according to the scheme described
timeFrame: Day of discharge (about 6 days after surgery)
measure: Feasibility of study design as assessed by number of participants for which safety was able to be assessed (EKGs)
timeFrame: postop days 1 and 5
measure: Feasibility of study design as assessed by the number of participants for which safety was able to be assessed (respiratory events)
timeFrame: Day of discharge (about 6 days after surgery)
measure: Feasibility of study design as assessed by the number of participants for which postop opioid usage could be surveyed at 3 months
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Number of participants for which opioid usage was able to be collected
timeFrame: Day of discharge (about 6 days after surgery)
measure: Safety as assessed by the number of patients developing respiratory depression
timeFrame: by fifth day of hospital stay
measure: Safety as assessed by the number of patients developing clinically significant corrected QT interval(QTc )prolongation
timeFrame: by fifth day of hospital stay
measure: Safety as assessed by the number of participants with hallucinations
timeFrame: by fifth day of hospital stay
measure: Safety as assessed by the number of participants with dizziness
timeFrame: by fifth day of hospital stay
measure: Safety as assessed by the number of participants with Antiemetic use
timeFrame: by fifth day of hospital stay
measure: Safety as assessed by the number of participants with occurrence of nausea
timeFrame: by fifth day of hospital stay
measure: Safety as assessed by the number of participants with occurrence of vomiting
timeFrame: by fifth day of hospital stay
measure: Safety as assessed by the number of participants with occurrence of Ileus or constipation
timeFrame: by fifth day of hospital stay
measure: Safety as assessed by the number of subjects with persistent opioid use
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Shobana Rajan, MD
role: PRINCIPAL_INVESTIGATOR
References: