Postoperative Pain
Conditions
Keywords
hydromorphone, lumbar posterior spinal fusion, lumbosacral spondylosis, Spinal Fusion
Brief summary
What is the influence of methadone on postoperative analgesia after lumbar interbody fusion in opioid naïve patients or patients who are taking less than equivalent of 15 mg IV morphine each day? What is the incidence of opioid related postoperative side effects after the administration of methadone in the operating room?
Detailed description
Hypothesis: 1. We hypothesize that 0.2 mg/kg of methadone will result in decreased postoperative hydromorphone consumption compared to hydromorphone alone in opioid naïve patients or patients who are taking less than the equivalent of 15 mg IV morphine a day undergoing lumbar interbody fusion. 2. We hypothesize that the incidence of opioid related postoperative side effects will not be increased by the administration of methadone in the operating room.
Interventions
DRUGMethadone
0.2 mg/kg methadone IV bolus
DRUGSaline
3 mL saline IV bolus
Sponsors
Northwestern University Feinberg School of Medicine
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* ASA physical status I, II, and III, male and non-pregnant female * English-speaking patients * Ages 18-75 years * Undergoing elective one or two level posterior lumbar interbody fusion
Exclusion criteria
* Use of more than the equivalent of 15 mg of IV morphine/24 hr in the past 2 weeks. * Use of drugs within the past 6 months that effect the pharmacokinetics or pharmacodynamics of opioids (i.e., benzodiazepines, anti-retroviral agents, rifampin, ketoconazole, erythromycin, or phenytoin). * history of substance abuse at any time in the past * known QT prolongation * Non-elective operations (i.e., cancer or trauma) * severe hepatic impairment (serum albumin \< 3.0 g/dL in the presence of a history of liver disease) * pregnancy * inability to operate a patient-controlled analgesia device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hydromorphone postoperative opioid consumption (POC) at 48 hours | 48 hrs | PCA opioid consumption during the initial postoperative 48 hours after arriving in the PACU |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain at rest and with movement (numerical Rating Scale, NRS) | 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs | — |
| Intraoperative remifentanil consumption | the 8 hours prior to arrival in the recovery room | intraoperative consumption of remifentanil--the amount of remifentanil used in the OR (i.e., the 2-8 hours prior to arrival in the recovery room) |
| the number of occurrences of ventilatory depression during each evaluation interval | 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs | — |
| the level of sedation (modified Observer's Assessment of Alertness and Sedation Scale, modified OAA/S scale) | 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs | — |
| recorded emesis | 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs | — |
| occurrence of pruritus | 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs | — |
| Hydromorphone postoperative opioid consumption (POC) | 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs | PCA opioid consumption at postoperative 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs after arriving in the PACU |
| number of occurrences of nausea (resulting in treatment) | 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs | — |
Countries
United States
Outcome results
None listed