Patient Satisfaction Clinical Trial
Official title:
Methadone and Hydromorphone For Spinal Surgery
NCT number | NCT02107339 |
Other study ID # | EH14-113 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | March 2014 |
Est. completion date | September 2017 |
Verified date | September 2019 |
Source | NorthShore University HealthSystem |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 120 |
Est. completion date | September 2017 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | NorthShore University HealthSystem | Evanston | Illinois |
Lead Sponsor | Collaborator |
---|---|
NorthShore University HealthSystem |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hydromorphone Use at 24 Hours | Use of hydromorphone at 24 hours | ||
Secondary | Hydromorphone Use Second 24 Hours | 24-48 hours after surgery | ||
Secondary | Hydromorphone Use Third 24 Hours | 48-72 hours after surgery | ||
Secondary | Pain Scores Postanesthesia Care Unit (PACU) Arrival | 11-point verbal rating scale (0=no pain, 10=worst pain imaginable) | First 5 minutes after PACU arrival | |
Secondary | Pain Scores 1 Hour After PACU Arrival | 11-point verbal rating scale (0=no pain, 10=worst pain imaginable) | Pain scores at 60 minutes after PACU admission | |
Secondary | Pain Scores 2 Hours After PACU Arrival | 11-point verbal rating scale (0=no pain, 10=worst pain imaginable) | Pain scores at 120 minutes after PACU admission | |
Secondary | Pain Scores on Postoperative Day One | 11-point verbal rating scale (0=no pain, 10=worst pain imaginable) | Pain scores one day after PACU admission | |
Secondary | Pain Scores on Postoperative Day 2 | 11-point verbal rating scale (0=no pain, 10=worst pain imaginable) | Pain scores 48 hours after PACU admission | |
Secondary | Pain Scores Postoperative Day 3 | 11-point verbal rating scale (0=no pain, 10=worst pain imaginable) | Pain scores 72 hours after PACU admission | |
Secondary | Patient Satisfaction Scores | Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best)) | Postopertive day 1 | |
Secondary | Patient Satisfaction Scores | Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best)) | postoperative day 2 | |
Secondary | Patient Satisfaction Scores | Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best)) | Postoperative day 3 | |
Secondary | Chronic Persistent Surgical Pain-Weekly Frequency of Pain | 0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant | One month after surgery | |
Secondary | Chronic Persistent Surgical Pain-weekly Frequency of Pain | 0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant | 3 months after surgery | |
Secondary | Chronic Persistent Surgical Pain-Weekly Frequency of Pain | 0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant | 6 months after surgery | |
Secondary | Chronic Persistent Surgical Pain-Weekly Frequency of Pain | 0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant | 12 months after surgery |
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