Postoperative Pain and Analgesic Requirements After Preoperative Methadone for Primary TKA

NCT06691633 | Completed Phase 4 FDA Drug

• 1 other identifier: 23.0752
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective, randomized study is to compare the outcomes of two cohorts of patients undergoing primary Total Knee Arthroplasty (TKA) and to determine whether a single dose of methadone administered preoperatively is effective at reducing postoperative opioid usage and postoperative pain versus a control group of patients receiving standard intraoperative opioids only for primary TKA. The main questions it aims to answer are:

• What is the efficacy of a single preoperative dose of methadone in reducing opioid consumption and postoperative pain in primary total knee arthroplasty?
• Will the study results demonstrate the effectiveness and safety of a single preoperative dose of methadone (10 mg) in primary total knee arthroplasty in reducing postoperative opioid usage while maintaining a similar or better level of pain control when compared to a standard pain control regimen? Researchers will compare Methadone to a standard pain control regimen (Oxycodone) to see if Methadone is equivalent or more effective at reducing opioid consumption and postoperative pain in primary total knee arthroplasty Participants will:
• be randomized into one of two groups
• undergo a primary TKA
• complete a tracking sheet documenting daily pain medicine usage and VAS pain level for the first 14 days following the TKA
• return to office at 2 weeks and 6 weeks postop for follow-up
• complete additional questionnaires at 2 weeks and 6 weeks postop

Conditions

Osteoarthritis (OA) of the Knee

Keywords

osteoarthritis; knee; total knee arthroplasty; prospective RCT; preoperative analgesia; Methadone

Outcome Measures

Primary Outcomes (3)

• Daily Opioid Use

  Daily Opioid Use as measured in MME recorded daily for the first two weeks following TKA

  2 weeks

• Total opioid usage over two weeks

  total daily opioid usage (as measured in MME) during the first 14 days following TKA

  2 weeks

• Visual Analogue Scale pain score

  Visual Analogue Scale knee pain score (minimum value: 0, maximum value: 10). Higher scores equate to a worse outcome (a score of zero = pain free).

  2 weeks

Secondary Outcomes (5)

• Hospital Length of Stay

  Up to 2 weeks

• Discharge location

  2 weeks

• Two and six-week narcotic refill

  6 weeks

• Knee Injury and Osteoarthritis Outcome Score, Joint Replacement score

  preoperatively and 6 weeks (± 2 weeks) postoperatively

• ROM

  preoperatively, 2 weeks and 6 weeks (± 2 weeks) postoperatively

Study Arms (2)

Methadone Group

EXPERIMENTAL

Participant receives a one-time preoperative dose of 10 mg of methadone

Drug: Preoperative Methadone

Oxycodone Group

ACTIVE COMPARATOR

participant receives a one-time preoperative dose of 10 mg of oral oxycodone

Drug: Preoperative Oxycodone

Interventions

Preoperative Methadone DRUG

patient receives a one-time preoperative dose of 10 mg of methadone

Methadone Group

Preoperative Oxycodone DRUG

patient receives a one-time preoperative dose of 10 mg of oral oxycodone

Oxycodone Group

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age is 21-89 at time of surgery
• Patient is scheduled to undergo a unilateral primary TKA, secondary to osteoarthritis
• Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
• Patient is able to read and speak English.

You may not qualify if:

• Patient is under the age of 21
• Patient's primary diagnosis is not osteoarthritis
• Patient is unable to read and speak English
• History of liver or kidney disease,
• Known or suspected GI obstruction
• Hypersensitivity to methadone
• Patients with significant respiratory depression
• Pregnant or nursing females

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

UofL Health

Louisville, Kentucky, 40202, United States

Location

Related Publications (8)

• Ferrari A, Coccia CP, Bertolini A, Sternieri E. Methadone--metabolism, pharmacokinetics and interactions. Pharmacol Res. 2004 Dec;50(6):551-9. doi: 10.1016/j.phrs.2004.05.002.

  PMID: 15501692 BACKGROUND

• Ebert B, Thorkildsen C, Andersen S, Christrup LL, Hjeds H. Opioid analgesics as noncompetitive N-methyl-D-aspartate (NMDA) antagonists. Biochem Pharmacol. 1998 Sep 1;56(5):553-9. doi: 10.1016/s0006-2952(98)00088-4.

  PMID: 9783723 BACKGROUND

• Duellman TJ, Gaffigan C, Milbrandt JC, Allan DG. Multi-modal, pre-emptive analgesia decreases the length of hospital stay following total joint arthroplasty. Orthopedics. 2009 Mar;32(3):167.

  PMID: 19309064 BACKGROUND

• Davis AM, Inturrisi CE. d-Methadone blocks morphine tolerance and N-methyl-D-aspartate-induced hyperalgesia. J Pharmacol Exp Ther. 1999 May;289(2):1048-53.

  PMID: 10215686 BACKGROUND

• Chui PT, Gin T. A double-blind randomised trial comparing postoperative analgesia after perioperative loading doses of methadone or morphine. Anaesth Intensive Care. 1992 Feb;20(1):46-51. doi: 10.1177/0310057X9202000109.

  PMID: 1609941 BACKGROUND

• Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.

  PMID: 19844772 BACKGROUND

• Bahreini M, Jalili M, Moradi-Lakeh M. A comparison of three self-report pain scales in adults with acute pain. J Emerg Med. 2015 Jan;48(1):10-8. doi: 10.1016/j.jemermed.2014.07.039. Epub 2014 Sep 27.

  PMID: 25271179 BACKGROUND

• Aasvang EK, Lunn TH, Hansen TB, Kristensen PW, Solgaard S, Kehlet H. Chronic pre-operative opioid use and acute pain after fast-track total knee arthroplasty. Acta Anaesthesiol Scand. 2016 Apr;60(4):529-36. doi: 10.1111/aas.12667. Epub 2015 Dec 28.

  PMID: 26708043 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Rodolfo Zamora, MD

  University of Louisville

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Clinical staff other than the anesthesia providers
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Model Details: Prospective, randomized cohort analysis study

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 15, 2024
• Study Start: February 19, 2024
• Primary Completion: September 24, 2024
• Study Completion: October 18, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)