A Trial Comparing Single Intra-op Dose of Methadone Versus Placebo in Patients Undergoing Spine Surgery
Condition: Thoracolumbar Scoliosis
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Scoliosis is a disease that involves lateral and/or rotational deformity of the spine and can
      affect up to 4% of the population. Typically, surgery is considered when Cobb's angle, which
      is a measurement used for evaluation of curves in scoliosis on an anterior-posterior
      radiographic projection of the spine, is greater than 50 degrees in the thoracic region (40
      degrees in the lumbar region) or when the curvature causes significant pain, or respiratory
      and cardiovascular restriction. Patient undergoing this surgical correction experience severe
      pain in the postoperative period and the management includes the use of opioid-based
      patient-controlled analgesia (PCA).
    

Detailed description: 
      Scoliosis is a disease that involves lateral and/or rotational deformity of the spine and can
      affect up to 4% of the population. Typically, surgery is considered when Cobb's angle, which
      is a measurement used for evaluation of curves in scoliosis on an anterior-posterior
      radiographic projection of the spine, is greater than 50 degrees in the thoracic region (40
      degrees in the lumbar region) or when the curvature causes significant pain, or respiratory
      and cardiovascular restriction. Patient undergoing this surgical correction experience severe
      pain in the postoperative period and the management includes the use of opioid-based
      patient-controlled analgesia (PCA).

      Methadone is an opioid with one of the longest elimination half-life and has been used as an
      effective analgesic for acute, chronic, neuropathic, and cancer pain in adults, children, and
      even neonates1-5. Its long duration of action and antagonism to the N-methyl-d-aspartate
      receptor may decrease the need for PCA use in the postoperative period. Gourlay2 demonstrated
      the effectiveness and utility of perioperative methadone including the advantages of longer
      analgesia with no serious side effects of respiratory depression. A recent study by
      Gottschalk2 in adult patients demonstrated a 50% reduction of postoperative opioids at 48
      hours and lower pain scores after a single bolus of methadone before surgical incision.
      However, a major weakness of the study is that patients did not receive equipotent
      intraoperative opioids. In addition, the adolescent patient population will undergo a much
      larger surgical incision with potential for greater postoperative pain. Despite this
      potential benefit, methadone is seldom used in the perioperative setting. A more recent
      pharmacokinetic study of methadone in adolescents undergoing spine surgery failed to show a
      reduction in opioid consumption as it was powered to determine pharmacokinetics and not a
      secondary endpoint of postoperative opioid consumption. An appropriately powered study is
      still required to determine the efficacy of methadone in reducing postoperative pain after
      spine surgery.
    

Intervention name(s): Methadone; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes; the control group will receive a 20 ml normal saline placebo infusion over 10 minutes
Other intervention name(s): Treatment group; Control Group
Intervention MeSH terms: Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment