Phase 4
N=120
Methadone and Hydromorphone For Spinal Surgery
Hydromorphone Use · Acute Postoperative Pain · Patient Satisfaction · Chronic Persistent Surgical Pain
Bottom Line
View on ClinicalTrials.gov: NCT02107339 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Hydromorphone Use at 24 Hours — 4.56; 9.9 milligrams
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Methadone (Drug); Hydromorphone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Endeavor Health
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hydromorphone Use at 24 Hours |
4.56; 9.9 | — |
| SECONDARY Hydromorphone Use Second 24 Hours |
0.6; 3.15 | — |
| SECONDARY Hydromorphone Use Third 24 Hours |
0; 0.35 | — |
| SECONDARY Pain Scores Postanesthesia Care Unit (PACU) Arrival |
5; 8 | — |
| SECONDARY Pain Scores 1 Hour After PACU Arrival |
4; 6 | — |
| SECONDARY Pain Scores 2 Hours After PACU Arrival |
4; 6 | — |
| SECONDARY Pain Scores on Postoperative Day One |
4; 5 | — |
| SECONDARY Pain Scores on Postoperative Day 2 |
4.56; 6 | — |
| SECONDARY Pain Scores Postoperative Day 3 |
4; 5 | — |
| SECONDARY Patient Satisfaction Scores |
95; 90 | — |
| SECONDARY Patient Satisfaction Scores |
95; 90 | — |
| SECONDARY Patient Satisfaction Scores |
95; 90 | — |
| SECONDARY Chronic Persistent Surgical Pain-Weekly Frequency of Pain |
0; 2 | — |
| SECONDARY Chronic Persistent Surgical Pain-weekly Frequency of Pain |
0; 2 | — |
| SECONDARY Chronic Persistent Surgical Pain-Weekly Frequency of Pain |
0; 2 | — |
| SECONDARY Chronic Persistent Surgical Pain-Weekly Frequency of Pain |
0; 2 | — |
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
Eligibility Criteria
Inclusion Criteria
- All patients presenting for elective posterior lumbar or thoracic spinal fusion surgery will be eligible for enrollment.
Exclusion Criteria
- Preoperative renal failure (defined as a serum creatinine > 2.0 mg/dL.)
- American Society of Anesthesiologists Physical Status IV or V
- Pulmonary disease necessitating home oxygen therapy
- Allergy to methadone or hydromorphone
- Preoperative recent history of opioid or alcohol abuse
- Inability to use a PCA device or speak the English language
Data sourced from ClinicalTrials.gov (NCT02107339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.