drugset / Trial / NCT02107339

Methadone and Hydromorphone For Spinal Surgery

NCT02107339

Phase 4 Completed 120 enrolled Endeavor Health
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start
2014-03
Primary completion
2016-07
Completion
2017-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hydromorphone Other / unclassified 2 mg
Subject Methadone Other / unclassified 0.2 mg/kg

Indications

No indication recorded.