CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 120 enrolled
Drug / intervention
Methadone +1 moredrug
Likely dose
Methadone 0.2 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02107339
NCT02107339Phase 4Completed

Methadone and Hydromorphone For Spinal Surgery

Endeavor Health·interventional·Posted Apr 8, 2014·Updated Sep 30, 2019

In Brief

A Phase 4 clinical trial evaluating Methadone and Hydromorphone for Hydromorphone Use and 3 related conditions. Completed, enrolled 120 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 8, 2014
Enrollment StartMar 1, 2014
Primary CompletionJul 1, 2016
Study CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.2 years ago

Interventions

Methadonedrug

Methadone 0.2 mg/kg administered at induction of anesthesia

Hydromorphonedrug

Hydromorphone 2 mg administered at the conclusion of anesthesia