The Effects of Ketamine and Methadone on Postoperative Pain for Laminectomy

Laminectomy Clinical Trial

Official title:

Intraoperative Ketamine and Methadone for Laminectomy: Effect on Recovery, Postoperative Pain, and Opioid Requirements

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02252432
• Other study ID #: Pro00030109
• Status: Terminated
• Phase: Phase 4
• Start date: February 2013
• Est. completion date: January 2023

Study information

• Verified date: February 2024
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

During and after the surgery, patients undergoing surgery most likely need narcotics (opioids) that can cause side effects such as drowsiness and constipation. This can delay your recovery. The investigator would like to determine if the intraoperative use of ketamine and methadone will provide better pain control and reduce the use of narcotic painkiller medications (analgesics) after lumbar surgery as compared to either drug (ketamine or methadone) alone. Ketamine is used to help to reduce the amount of the commonly used intravenous anesthetic drugs, minimize heart rate and blood pressure instability during surgery, and to improve outcomes after surgery (e.g. less pain, less constipation, less nausea and vomiting after surgery, faster return of bowel function and shortened length of hospital stay). Ketamine is approved by the U.S. Food and Drug Administration (FDA) to be used: as an anesthetic and analgesic (painkiller). Ketamine is an "adjuvant," which is a drug that may increase the effectiveness or strength of other drugs when given at the same time. Ketamine is administered as an adjuvant during anesthesia to produce anesthetic and analgesic-sparing effects (reduce the amount of anesthetics and narcotics-painkiller drugs), hemodynamic stability (to maintain the blood pressure and heart rate within normal rank) and side effect reduction (e.g., constipation, nausea and vomiting, itching, and urinary retention). Ketamine will be used as approved in this study. Ketamine is frequently used intraoperatively for pain control in patients undergoing spine surgery at our institution and is within the standard of care. The standard of care indicates that this is one possible method which has been demonstrated to be safe and effective for patient care. This may vary at different institutions. Methadone is approved by the U.S. Food and Drug Administration (FDA) to be used: as an opioid pain reliever, similar to morphine, and for narcotic detoxification to reduce withdrawal symptoms. The dose of methadone that will be used in this study may be slightly higher than the approved dose depending on the subject's weight. However, this dose of methadone is frequently used intraoperatively for pain control in patients undergoing spine surgery at our institution and is within the standard of care. This may vary at different institutions.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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
• Morbid obesity (BMI > 40 kg/m2) AND/OR weight > 150 kg
• Chronic renal failure ( creatinine > 2.0 mg/dL)
• Liver failure e.g., active cirrhosis
• Alcohol or substance abuse within in the past 3 months
• Uncorrected hypokalemia, hypomagnesemia, hypocalcemia (can be due to diuretics, mineralocorticoid use, laxatives)
• Chronic obstructive pulmonary disease (COPD)/Hypercarbia
• Restrictive lung disease (pulmonary fibrosis, myasthenia gravis)
• Congestive heart failure
• Thyroid disease
• Organ transplant patients
• Drugs/substances known to inhibit methadone metabolism: macrolide antibiotics e.g., erythromycin, cimetidine, astemizole, voriconazole, grapefruit juice

Related Conditions & MeSH terms

• Laminectomy
• Pain, Postoperative

Intervention

Drug:
• Ketamine
A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min)
• Methadone
A single dose of IV methadone (0.2 mg/kg) preinduction.
• Ketamine + methadone
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)

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Nausea and Vomiting	The number of participants who experienced nausea and vomiting	1 day
Secondary	Number of Participants With Constipation at Follow up	Day one, day three after surgery	3 days