Methadone and Hydromorphone For Spinal Surgery

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NorthShore University HealthSystem; NorthShore University HealthSystem Research Institute
• Treatments: Hydromorphone; Methadone

Criteria

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