Intraoperative Methadone vs Morphine for Postoperative Pain Control in Patients Undergoing Surger… (NCT01430182) | Clinical Trial Compass
TerminatedNot Applicable
Intraoperative Methadone vs Morphine for Postoperative Pain Control in Patients Undergoing Surgery of the Tibia
Stopped: Shortages of study drug, difficulty enrolling patients
United States17 participantsStarted 2011-09
Plain-language 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 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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. Associ…
What they're measuring
1
Opioid Consumption
Timeframe: First 24 hours after discharge from Post-Anesthesia Care Unit