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Methadone and Hydromorphone For Spinal Surgery

CompletedPhase 4NCT02107339
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

Patients undergoing major spinal surgery continue to experience moderate-to-severe pain during the first 2-3 days following the operative procedure. Pain complicates the recovery process, despite the routine practice of using potent opioid analgesics. The primary reason that pain is poorly controlled in patients undergoing major surgery is that most commonly-used opioids only produce analgesia for 2-4 hours. The intermittent use of these drugs results in periods of time when a patient will experience discomfort (at which time a nurse administers more drug or the button on a patient-controlled analgesic (PCA) system is pressed to deliver more medication). The use of a long-acting opioid may be advantageous in the perioperative setting. Methadone is an opioid that has a median duration of analgesia of 24-36 hours. Therefore, a single dose administered in the operating room may reduce the need for pain medication and improve pain control for the first few postoperative days. The aim of this randomized clinical trial is to examine the effect of methadone (compared to hydromorphone) on postoperative pain management in patients undergoing major spine surgery

Study details

Official title
Methadone and Hydromorphone For Spinal Surgery
Conditions
Interventions
Sponsor
Endeavor Health
Start date
2014-03
Primary completion
2016-07
Sex
All
Age range
from 18 Years to 80 Years
Healthy volunteers
true
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * All patients presenting for elective posterior lumbar or thoracic spinal fusion surgery will be eligible for enrollment. Exclusion Criteria: 1. Preoperative renal failure (defined as a serum creatinine \> 2.0 mg/dL.) 2. American Society of Anesthesiologists Physical Status IV or V 3. Pulmonary disease necessitating home oxygen therapy 4. Allergy to methadone or hydromorphone 5. Preoperative recent history of opioid or alcohol abuse 6. Inability to use a PCA device or speak the English language

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02107339