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Recruiting NCT07485803

Methadone in the Management of Post-Operative Pain in Total Knee Replacement

Phase IV Interventional Total Knee Arthroplasty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Methadone.
Who it may be relevant to
Registry conditions: Total Knee Arthroplasty. Basic parameters: 21 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Randomized Trial Utilizing Methadone in the Management of Post-Operative Pain in Total Knee Replacement

Overview

The goal of this study is to determine whether one dose of IV methadone given right before surgery will help patients' pain management after a total knee replacement and reduce the amount of pain medications taken in the weeks after surgery.

Interventions

  • Drug Methadone
    Subjects randomized to receive methadone will be given one dose of methadone 0.15mg/kg intravenously dosed based on ideal body weight administered by the anesthesia team prior to surgical incision

Primary outcome measures

  • Opioid use for 48 hours post-operatively [Time frame: 48 hours after TKA procedure]
Secondary outcome measures (7)
  • Defense and Veterans Pain Scale [Time frame: 2 weeks after TKA procedure]
  • Opioid-Related Symptom Distress Scale (ORSDS) [Time frame: At baseline and 2 weeks after TKA procedure]
  • Pittsburgh Sleep Quality Index [Time frame: At baseline and 2 weeks after TKA procedure]
  • Total opioid usage over 2 weeks post-operatively [Time frame: 2 weeks after TKA procedure]
  • Knee Society Score [Time frame: At baseline]
  • KOOS-12 Knee Survey [Time frame: At baseline]
  • Veterans Rand 12-Item Health Survey (VR-12) [Time frame: At baseline]

Eligibility criteria

Inclusion criteria

  • Provision of signed and dated informed consent from
  • Stated willingness to comply with all study procedures and availability to attend all required visits for the duration of the study.
  • Age 21- 75
  • Unilateral total knee arthroplasty at Colorado Joint Replacement
  • All individuals will be screened for drug use (opioid use, illicit drug use) at their preoperative appointment
  • For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.

Exclusion criteria

  • Narcotic use in the past 6 weeks
  • Current or previous history of drug and alcohol abuse
  • Tobacco use in the previous 90 days
  • Treatment with another investigational drug
  • Patients that cannot receive spinal anesthesia
  • Patients that cannot receive the standardized multimodal pain medications (i.e. Tylenol, gabapentin and meloxicam)'
  • Patients that are not able to go home after leaving the hospital and require a short-term rehabilitation facility
  • Obstructive sleep apnea
  • Morbid obesity (BMI >40)
  • Patients with liver disease.
  • Significant kidney disease - stage 3 CKD or greater
  • Pregnant or nursing females
  • Baseline QTc >480
  • severe COPD (GOLD 3 or 4)
  • home oxygen requirement

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • AdventHealth Porter — Denver

Publications

  • Kharasch ED. Intraoperative methadone: rediscovery, reappraisal, and reinvigoration? Anesth Analg. 2011 Jan;112(1):13-6. doi: 10.1213/ANE.0b013e3181fec9a3. No abstract available. PMID 21173206
  • 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. PMID 29847382
  • Friesgaard KD, Brix LD, Kristensen CB, Rian O, Nikolajsen L. Clinical effectiveness and safety of intraoperative methadone in patients undergoing laparoscopic hysterectomy: a randomised, blinded clinical trial. BJA Open. 2023 Aug 5;7:100219. doi: 10.1016/j.bjao.2023.100219. eCollection 2023 Sep. PMID 37638083
  • Morris BJ, Mir HR. The opioid epidemic: impact on orthopaedic surgery. J Am Acad Orthop Surg. 2015 May;23(5):267-71. doi: 10.5435/JAAOS-D-14-00163. PMID 25911660
  • Menendez ME, Ring D, Bateman BT. Preoperative Opioid Misuse is Associated With Increased Morbidity and Mortality After Elective Orthopaedic Surgery. Clin Orthop Relat Res. 2015 Jul;473(7):2402-12. doi: 10.1007/s11999-015-4173-5. Epub 2015 Feb 19. PMID 25694266
  • Cancienne JM, Patel KJ, Browne JA, Werner BC. Narcotic Use and Total Knee Arthroplasty. J Arthroplasty. 2018 Jan;33(1):113-118. doi: 10.1016/j.arth.2017.08.006. Epub 2017 Aug 17. PMID 28887020
  • Li WT, Bell KL, Yayac M, Barmann JA, Star AM, Austin MS. A Postdischarge Multimodal Pain Management Cocktail Following Total Knee Arthroplasty Reduces Opioid Consumption in the 30-Day Postoperative Period: A Group-Randomized Trial. J Arthroplasty. 2021 Jan;36(1):164-172.e2. doi: 10.1016/j.arth.2020.07.060. Epub 2020 Jul 30. PMID 33036845

Identifiers

NCT: NCT07485803 · 2387801

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗