Status:
TERMINATED
Intraoperative Methadone vs Morphine for Postoperative Pain Control in Patients Undergoing Surgery of the Tibia
Lead Sponsor:
Baylor College of Medicine
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether, for surgery of the tibia, one dose of methadone provides better control of pain afterward as compared to morphine, which is the usual drug given to c...
Detailed Description
Satisfactory pain control can generally be achieved after major surgery of the tibia through a combination of enteral and parenteral medications, neuraxial techniques (such as epidural analgesia), and...
Eligibility Criteria
Inclusion
- Subjects scheduled for elective, non-emergent intramedullary nailing (IMN) or open reduction/internal fixation (ORIF) of the tibia at Ben Taub General Hospital
- Able to give consent (not cognitively impaired or intoxicated)
- Subjects must be 18-50 years of age
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for primary intramedullary nailing or open reduction/internal fixation of fractures of the tibial shaft or proximal tibia. This must be the first operation for this injured extremity.
- Associated fractures of the fibula will be allowed.
- Minor lacerations or other associated injuries like "road rash" or open wounds requiring skin graft are permitted
Exclusion
- Subjects who have taken preoperative opioids for more than 7 days before surgery (i.e., tolerant)
- Regular use of opioids (whether recreational/illicit or prescribed) within the six months before injury
- Subjects who are recommended to receive a regional nerve block or a neuraxial technique (spinal or epidural) by the attending orthopedic surgeon
- Subjects who refuse general anesthesia
- Subjects deemed to be moderately or severely hypovolemic
- External fixator already in place on the injured extremity
- Presence of other moderate-to-severe or distracting injuries, such as orthopedic, cervical spine, neurological, intra-abdominal, or intra-thoracic injuries. Minor abrasions/lacerations such as "road rash" or open wounds are acceptable. Associated fibular injuries are acceptable. Small peripheral injuries such as a finger or toe requiring percutaneous pinning are acceptable. Small skin grafts (no more than 100 cm\^2) are permitted
- Pregnancy or breastfeeding (verify urine pregnancy test)
- Associated or pre-existing head injury or Traumatic Brain Injury
- Difficulty or inability to understand the study or the protocol
- Severe obesity (BMI \> 36.0 kg/m\^2)
- Known respiratory or cardiovascular problems, such as obstructive sleep apnea, or oxygen saturation of less than 96% on room air
- Acute bronchial asthma
- Chronic renal failure (serum creatinine \> 2.0 mg/dL)
- Liver failure (defined as history of cirrhosis or fulminant hepatic failure)
- History of myocardial infarction or heart failure
- History of prolonged QT syndrome (QTc 450ms or more for men and 460ms or more for women)
- Known contraindications to methadone including hypothyroidism, Addison's disease, prostatic hypertrophy, or urethral stricture
- History of allergic reaction to morphine, methadone, acetaminophen, or hydrocodone
- Taking medications known to induce or inhibit the cytochrome p450 enzyme systems, such as azole antifungals, macrolide antibiotics, and selective serotonin reuptake inhibitors
- Taking antiretroviral medications (any)
- Consumption of grapefruit or grapefruit juice within past 5 days
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01430182
Start Date
September 1 2011
End Date
July 1 2014
Last Update
April 4 2016
Active Locations (1)
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1
Ben Taub General Hospital
Houston, Texas, United States, 77030