Methadone vs Magnesium in Spinal Fusion

Idiopathic Scoliosis Clinical Trial

Official title:

Analgesia Following Posterior Spinal Fusion: Methadone vs Magnesium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01795495
• Other study ID #: IRB13-0036
• Secondary ID: Active
• Status: Completed
• Phase: Phase 2
• First received: February 18, 2013
• Last updated: February 6, 2018
• Start date: September 2013
• Est. completion date: September 2016

Study information

• Verified date: February 2018
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Scoliosis
• Scoliosis

Intervention

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
• 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).
• Remifentanil

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra- and Post-operative Pain Relief	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.	Intra-operative and 24 hours post-operatively
Secondary	Post-operative Pain Scores	VAS pain score - 0 being no pain and 10 being worst pain.	Post-operatively to 24 hours