Methadone vs Magnesium in Spinal Fusion

Study Description

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Brief Summary:

Significant pain may occur following posterior spinal fusion despite the use of conventionally accepted techniques including patient controlled analgesia. If detected, a significant reduction in opioid requirements may lead to improved patient satisfaction and decreased opiate side effects.

The current study would use a prospective, randomized trial investigating the efficacy of one of 2 regimens as adjuncts to intraoperative anesthesia and postoperative analgesia, along with a third control group. The patients would be randomized to receive remifentanil plus a single intraoperative dose of methadone; remifentanil plus a bolus followed by an infusion of magnesium; or remifentanil alone. In addition, the two medications being studied might make it easier to determine the efficacy of neurophysiologic monitoring including somatosensory evoked potential (SSEP) (amplitude and latency) and motor evoked potential (MEP) (mA) required to elicit the response.

The purpose of this study would be to explore the effects of intraoperative methadone vs magnesium on intraoperative anesthetic requirements, postoperative opioid requirements, the efficacy of neurophysiologic monitoring including SSEP and MEP, inspired concentration of desflurane, remifentanil, and the need for intraoperative supplemental agents to control blood pressure.

Condition or disease	Intervention/treatment	Phase
Idiopathic Scoliosis	Drug: Methadone hydrochloride; Drug: Magnesium Sulfate; Drug: Remifentanil	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	63 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Supportive Care
Official Title:	Analgesia Following Posterior Spinal Fusion: Methadone vs Magnesium
Study Start Date :	September 2013
Actual Primary Completion Date :	August 2016
Actual Study Completion Date :	September 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Remifentanil; This arm will receive remifentanil alone as is the current practice.	Drug: Remifentanil
Experimental: Remifentanil plus methadone; This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.	Drug: Methadone hydrochloride; This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia; Other Name: Methadone
Experimental: Remifentanil plus magnesium; This arm will receive the current analgesic remifentanil plus an adjunct dose of magnesium sulfate.	Drug: Magnesium Sulfate; This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour).; Other Name: Magnesium

Outcome Measures

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Primary Outcome Measures :

1. Intra- and Post-operative Pain Relief [ Time Frame: Intra-operative and 24 hours post-operatively ]
   To prospectively compare the effects of intra-operative methadone and magnesium on postoperative opioid requirements. Total amount of hydromorphone administered in OR, recovery room (PACU), and on the inpatient ward 24 hours post-operatively.

Secondary Outcome Measures :

1. Post-operative Pain Scores [ Time Frame: Post-operatively to 24 hours ]
   VAS pain score - 0 being no pain and 10 being worst pain.

Eligibility Criteria

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Ages Eligible for Study:	12 Years to 19 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Patients older than 12, and younger than 19 years of age undergoing posterior spinal fusion for idiopathic scoliosis
• American Society of Anesthesiologist (ASA) physical status I or II
• Parents/Guardian willing and able to authorize informed consent
• Patients willing and able to authorize assent

Exclusion Criteria:

• Patients presenting with neuromuscular scoliosis
• Patients deemed at increased risk of adverse reactions due to the presence of pre-existing severe organ system dysfunction, including debilitating lung disease, severe obstructive sleep apnea, severe congenital or acquired heart disease, and/or severe renal impairment
• Patients who are both being currently treated for a psychological disorder and have a history of hospitalization for said disorder

Contacts and Locations

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Locations

United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205

Sponsors and Collaborators

Nationwide Children's Hospital

Investigators

Principal Investigator:	David P. Martin, MD	Nationwide Children's Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Stemland CJ, Witte J, Colquhoun DA, Durieux ME, Langman LJ, Balireddy R, Thammishetti S, Abel MF, Anderson BJ. The pharmacokinetics of methadone in adolescents undergoing posterior spinal fusion. Paediatr Anaesth. 2013 Jan;23(1):51-7. doi: 10.1111/pan.12021. Epub 2012 Sep 14.

Sharma A, Tallchief D, Blood J, Kim T, London A, Kharasch ED. Perioperative pharmacokinetics of methadone in adolescents. Anesthesiology. 2011 Dec;115(6):1153-61. doi: 10.1097/ALN.0b013e318238fec5.

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.

Elsharnouby NM, Elsharnouby MM. Magnesium sulphate as a technique of hypotensive anaesthesia. Br J Anaesth. 2006 Jun;96(6):727-31. Epub 2006 May 2.

Levaux Ch, Bonhomme V, Dewandre PY, Brichant JF, Hans P. Effect of intra-operative magnesium sulphate on pain relief and patient comfort after major lumbar orthopaedic surgery. Anaesthesia. 2003 Feb;58(2):131-5.

Responsible Party:	David P. Martin, Clinical Assistant Professor, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:	NCT01795495 History of Changes
Other Study ID Numbers:	IRB13-0036; Active ( Other Grant/Funding Number: Nationwide Children's Hospital Intramural Grant - 292913 )
First Posted:	February 20, 2013
Results First Posted:	February 8, 2018
Last Update Posted:	February 8, 2018
Last Verified:	February 2018

Keywords provided by David P. Martin, Nationwide Children's Hospital:

Spinal Fusion; Scoliosis; Methadone	Magnesium; Adolescents; Back Surgery

Additional relevant MeSH terms:

Scoliosis; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Analgesics; Remifentanil; Methadone; Magnesium Sulfate; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Analgesics, Opioid; Narcotics	Central Nervous System Depressants; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Antitussive Agents; Respiratory System Agents; Anti-Arrhythmia Agents; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Tocolytic Agents; Reproductive Control Agents