The Effects of Ketamine and Methadone on Postoperative Pain for Laminectomy
| Status: | Recruiting |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 2/1/2019 |
| Start Date: | February 2013 |
| End Date: | December 2020 |
| Contact: | Roya Yumul, M.D., PhD. |
| Email: | Roya.Yumul@cshs.org |
| Phone: | 310-423-1682 |
Intraoperative Ketamine and Methadone for Laminectomy: Effect on Recovery, Postoperative Pain, and Opioid Requirements
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.
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.
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.
(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.
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
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Phone: 310-423-5841
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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