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

NCT01430182 | Terminated Results

• 1 other identifier: H-28734
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pain, Postoperative

Keywords

Adult; Female; Humans; Intraoperative Care/methods; Male; Methadone/administration & dosage; Analgesics/therapeutic use; Methadone/therapeutic use; Morphine/therapeutic use; Middle Aged; Pain Measurement/drug effects; Pain Measurement/methods; Pain, Postoperative/prevention & control; Prospective Studies; Double-Blind Method; Tibial Fractures/surgery; Young Adult; Orthopedics

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  Number of morphine equivalents used by subject during first 24 hours after discharge from Post-Anesthesia Care Unit

  First 24 hours after discharge from Post-Anesthesia Care Unit

Study Arms (2)

Methadone 0.2 mg/kg

EXPERIMENTAL

0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.

Drug: Methadone

Morphine 0.2 mg/kg

ACTIVE COMPARATOR

0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.

Drug: Morphine

Interventions

Methadone DRUG

0.2 mg\*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete.

Also known as: Bioniche Pharma, METHADONE HYDROCHLORIDE INJECTION

Methadone 0.2 mg/kg

Morphine DRUG

0.2 mg\*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete.

Also known as: Morphine sulfate

Morphine 0.2 mg/kg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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)

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

Related Publications (5)

• Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.

  PMID: 20418538 BACKGROUND

• Gourlay GK, Willis RJ, Lamberty J. A double-blind comparison of the efficacy of methadone and morphine in postoperative pain control. Anesthesiology. 1986 Mar;64(3):322-7. doi: 10.1097/00000542-198603000-00004.

  PMID: 3954126 BACKGROUND

• Gourlay GK, Willis RJ, Wilson PR. Postoperative pain control with methadone: influence of supplementary methadone doses and blood concentration--response relationships. Anesthesiology. 1984 Jul;61(1):19-26.

  PMID: 6742480 BACKGROUND

• Gourlay GK, Wilson PR, Glynn CJ. Pharmacodynamics and pharmacokinetics of methadone during the perioperative period. Anesthesiology. 1982 Dec;57(6):458-67. doi: 10.1097/00000542-198212000-00005. No abstract available.

  PMID: 6128949 BACKGROUND

• Gourlay GK, Wilson PR, Glynn CJ. Methadone produces prolonged postoperative analgesia. Br Med J (Clin Res Ed). 1982 Feb 27;284(6316):630-1. doi: 10.1136/bmj.284.6316.630. No abstract available.

  PMID: 6802264 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Pain; Tibial Fractures

Interventions

Methadone; Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed. Shortages of IV methadone prompted closure of trial.

Results Point of Contact

• Title: Neil Bailard
• Organization: Baylor College of Medicine

bailard@bcm.edu

713-798-7356

Study Officials

• Neil S Bailard, MD

  Dept. of Anesthesiology, Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anesthesiology

Study Record Dates

• First Submitted: September 6, 2011
• First Posted: September 8, 2011
• Study Start: September 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 4, 2016
• Results First Posted: April 4, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)