The Effects of Ketamine and Methadone on Postoperative Pain for Laminectomy

NCT02252432 | Terminated Phase 4 Results

• 1 other identifier: Pro00030109
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to determine the pain-reducing effects of ketamine (Ketalar, an FDA-approved drug for anesthesia) and methadone (Dolophine, a long-acting narcotic) after lumbar laminectomy. The investigators would like to evaluate whether intraoperative use of both drugs may be able to provide better control of pain after lumbar surgery.

Conditions

Laminectomy

Keywords

KETAMINE; METHADONE; POSTOPERATIVE PAIN; OPIOID REQUIREMENTS; Length of hospital stay; Perioperative outcomes

Outcome Measures

Primary Outcomes (2)

• Opioid Consumption Obtained From the Recorded Data

  Perioperative use of opioid consumption inside the hospital (recorded by study staff and data obtained from patient charts)

  1 day

• Postoperative Pain

  Postoperative pain was measured at PACU using a Verbal Rating Scale from 0 to 10. Where 0= no pain and 10= maximum pain experienced

  1 day

Secondary Outcomes (2)

• Nausea and Vomiting

  1 day

• Number of Participants With Constipation at Follow up

  3 days

Study Arms (3)

Ketamine

ACTIVE COMPARATOR

A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min))

Drug: Methadone; Drug: Ketamine + methadone

Methadone

ACTIVE COMPARATOR

Will receive a single dose of IV methadone (0.2 mg/kg) preinduction

Drug: Ketamine; Drug: Ketamine + methadone

Ketamine + methadone

EXPERIMENTAL

Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)

Drug: Ketamine; Drug: Methadone

Interventions

Ketamine DRUG

A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min)

Ketamine + methadone; Methadone

Methadone DRUG

A single dose of IV methadone (0.2 mg/kg) preinduction.

Ketamine; Ketamine + methadone

Ketamine + methadone DRUG

Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)

Ketamine; Methadone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 18 - 80 years old of either gender, scheduled for elective lumbar laminectomy

You may not qualify if:

• American Society of Anesthesiologists (ASA) IV and above
• Intolerance, allergy, or contraindication to use of any medications used in this study
• Significant coronary artery disease (abnormal stress test, myocardial infarction
• within the last 3 months)
• Increased intraocular pressure (e.g., untreated glaucoma)
• Uncontrolled hypertension (BP \> 140/90)
• Sleep apnea and currently on continuous positive airway pressure (CPAP)
• Increased intracranial pressure or clinical signs thereof
• History of intracranial surgery, stroke, or brain aneurysm
• Cardiac arrhythmias particularly prolonged QT syndrome
• Drugs known to cause prolonged qT: class (IA) antiarrhythmics (quinidine, procainamide, disopyramide), class III antiarrhythmics (sotalol, dofetilide, ibutilide, amiodarone), haloperidol, thioridazine, arsenic trioxide, HIV protease inhibitors, tricyclic antidepressants
• Individuals with significant psychological disorders including: schizophrenia, mania, bipolar disorder or psychosis
• Pregnant or lactating women
• Emergent laminectomy
• Those already receiving ketamine or methadone prior to surgery

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketamine; Methadone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ketones

Results Point of Contact

• Title: Ofelia Loani Elvir Lazo, MD
• Organization: Cedars Sinai Medical Center

Loani.Elvir-Lazo@cshs.org

310-423-1682

Study Officials

• Roya Yumul, M.D., PhD.

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: September 30, 2014
• Study Start: February 1, 2013
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: February 29, 2024
• Results First Posted: February 29, 2024

Record last verified: 2024-02

Locations

US (1)