Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial Comparing Single Intra-op Dose of Methadone Versus Placebo in Patients Undergoing Spine Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02206685
Recruitment Status : Unknown
Verified December 2016 by Kim Nguyen, Baylor College of Medicine.
Recruitment status was:  Recruiting
First Posted : August 1, 2014
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
Kim Nguyen, Baylor College of Medicine

Brief 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).

Condition or disease Intervention/treatment Phase
Thoracolumbar Scoliosis Drug: Methadone Drug: Normal Saline Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Blinded Prospective Trial Comparing Single Intraoperative Dose of Methadone Versus Placebo in Pediatric Patients Undergoing Spine Surgery.
Study Start Date : May 2014
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arm Intervention/treatment
Active Comparator: Treatment group
The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes.
Drug: Methadone
The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes
Other Name: Treatment group

Placebo Comparator: Control Group
The control group will receive a 20 ml normal saline placebo infusion over 10 minutes
Drug: Normal Saline
the control group will receive a 20 ml normal saline placebo infusion over 10 minutes
Other Name: Control Group




Primary Outcome Measures :
  1. Opioid Usage [ Time Frame: 5 days post op ]
    The primary endpoints is the total opioid usage during POD (postoperative day) 0-4.


Secondary Outcome Measures :
  1. Pain Scores [ Time Frame: 5 days ]
    Secondary endpoints include and pain scores during rest and with activity (getting out bed and ambulation) on POD 0-5 and side effects of pain medications



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patient age 10 - 17 years
  2. Patients undergoing multilevel thoraco-lumbar spine surgery with instrumentation and fusion

Exclusion Criteria:

  1. Preoperative methadone therapy
  2. Inability to use the PCA
  3. Allergy to methadone or morphine
  4. Morbid obesity with a body mass index >36.0 kg/m2
  5. Patients with chronic renal failure defined by serum creatinine >2.0 mg/dL
  6. Liver failure defined as a history of cirrhosis or fulminant hepatic failure
  7. Preoperative congenital heart disease or arrhythmias
  8. Patient refusal to participate in study
  9. Pregnancy (It is standard of care for all post menarche female patients to undergo a urine pregnancy test prior to surgery).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02206685


Contacts
Layout table for location contacts
Contact: Samantha Capehart, RN 832-824-5913 capehart@bcm.edu

Locations
Layout table for location information
United States, Texas
Texas Children't Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Kim Nguyen, MD    832-824-5800    ktn@bcm.edu   
Contact: Mehernoor F Watcha, MD    832-824-5800    watcha@bcm.edu   
Principal Investigator: Kim Nguyen, MD         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Kim Nguyen, MD Baylor College of Medicine

Publications:
Layout table for additonal information
Responsible Party: Kim Nguyen, Pediatric Anesthesiologist, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02206685     History of Changes
Other Study ID Numbers: H32894
First Posted: August 1, 2014    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents