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Methadone and Ketamine for Spinal Surgery

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ClinicalTrials.gov Identifier: NCT02827526
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : March 16, 2017
Sponsor:
Information provided by (Responsible Party):
Glenn S. Murphy, MD, NorthShore University HealthSystem Research Institute

Brief Summary:
Patients undergoing major spinal surgery continue to experience moderate-to-severe pain during the first 2-3 days following the operative procedure. Several factors contribute to postoperative pain in this patient population. Many patients present to surgery dependent on relatively high doses of oral opioids; this daily administration leads to tolerance to the effects of these drugs as well as hyperalgesia (exposure to opioids makes subsequent pain worse). In addition, surgical procedures on the spine are very painful. Furthermore, most of the opioids used after surgery only produce analgesia (pain relief) for 2-4 hours, which leads to fluctuations in levels of pain control (patients have to push a button to deliver pain medication when they begin to feel discomfort). Recent data suggest that the use of a long-acting opioid like methadone in the operating room, which provides analgesia for 24-36 hours, may improve pain control after spinal fusion surgery. However, other pain treatment modalities are required in this patient population. Studies have demonstrated that ketamine, a drug that prevents pain by a mechanism different from opioids, is effective in reducing pain medication requirements when given in the perioperative period. Small-dose infusions not only provide analgesia, but also prevent opioid tolerance and hyperalgesia. In particular, the combination of methadone and ketamine may be especially effective in controlling pain in patients following major operations. The aim of this randomized clinical trial is to examine the effect of a low-dose perioperative infusion of ketamine, when given with methadone in the operating room, on postoperative pain medication requirements, pain scores, and clinical recovery characteristics after spinal fusion surgery.

Condition or disease Intervention/treatment Phase
Pain Drug: Ketamine Drug: Control Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Methadone and Ketamine for Spinal Surgery
Study Start Date : July 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Ketamine
Patients in the ketamine arm will receive an intraoperative and postoperative infusion of ketamine
Drug: Ketamine
Placebo Comparator: Control
Patients in the control arm will receive an intraoperative and postoperative infusion of dextrose
Drug: Control
Other Name: dextrose infusion



Primary Outcome Measures :
  1. hydromorphone consumption [ Time Frame: first 24 hours ]

Secondary Outcome Measures :
  1. hydromorphone consumption [ Time Frame: second 24 hours ]
  2. hydromorphone consumption [ Time Frame: third 24 hours ]
  3. postoperative pain [ Time Frame: morning of postoperative day 1 ]
    scale of 0 to 10 (0=no pain 10=worst pain imaginable))

  4. postoperative pain [ Time Frame: morning of postoperative day 2 ]
    scale of 0 to 10, 0=no pain, 10=worst pain imaginable)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients presenting for elective posterior spinal fusion surgery (lower thoracic, lumbar, sacral)
  • Ages 18-80

Exclusion Criteria:

  • Preoperative renal failure (defined as a serum creatinine > 2.0 mg/dL.)
  • American Society of Anesthesiologists Physical Status IV or V
  • Pulmonary disease necessitating home oxygen therapy
  • Allergy to methadone, hydromorphone, or ketamine
  • Preoperative recent history of opioid or alcohol abuse
  • Significant liver disease
  • Inability to use a PCA device or speak the English language

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): NCT02827526


Contacts
Contact: Glenn S Murphy, MD 847-570-2760 dgmurphy2@yahoo.com

Locations
United States, Illinois
NorthShore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Glenn S Murphy, MD    847-570-2760    dgmurphy2@yahoo.com   
Sponsors and Collaborators
NorthShore University HealthSystem Research Institute
Investigators
Principal Investigator: Glenn S Murphy, MD NorthShore University HealthSystem

Responsible Party: Glenn S. Murphy, MD, Director Clinical Research, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier: NCT02827526     History of Changes
Other Study ID Numbers: EH15-268
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: March 16, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Ketamine
Methadone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Antitussive Agents
Respiratory System Agents