Intraoperative Methadone vs Morphine for Postoperative Pain Control in Patients Undergoing Surgery of the Tibia

Stopped early · Not applicable

Conditions studied: Pain, Postoperative

In brief

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 control pain after surgery. Immediately after the beginning of general anesthesia ("intraoperatively"), subjects will receive one dose of either methadone or morphine, in the amount of 0.2 milligrams per kilogram of body weight, intravenously. The primary hypothesis is that, subjects who receive one dose of methadone intraoperatively will require less pain medicine than subjects who receive one dose of morphine intraoperatively.

Key facts

Study ID

NCT01430182

Run by

Baylor College of Medicine

People needed

17

Starts

2011-09-01

Expected to finish

2014-07-01

Last updated by the study team

2016-04-04

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ben Taub General Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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