LaminectomyPhase 4NCT02252432
The Effects of Ketamine and Methadone on Postoperative Pain for Laminectomy
A Phase 4 study testing Ketamine, Methadone and Ketamine + methadone in people with Laminectomy, run by Cedars-Sinai Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Laminectomy
- What is being tested?
- Ketamine, Methadone and Ketamine + methadone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jan 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 80 years old of either gender, scheduled for elective lumbar laminectomy
Who cannot join
- 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)
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Laminectomy
- Being tested
- Ketamine, Methadone, Ketamine + methadone
- Keywords
- KETAMINE, METHADONE, POSTOPERATIVE PAIN, OPIOID REQUIREMENTS, Length of hospital stay, Perioperative outcomes
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min)
MethadoneDrug
A single dose of IV methadone (0.2 mg/kg) preinduction.
Ketamine + methadoneDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| 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)) Receives: Drug: Methadone; Drug: Ketamine + methadone |
| Methadone | Active comparator | Will receive a single dose of IV methadone (0.2 mg/kg) preinduction Receives: 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) Receives: Drug: Ketamine; Drug: Methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 1 day
Secondary outcomes (2)
Nausea and Vomiting
The number of participants who experienced nausea and vomiting
Measured: 1 day
Number of Participants With Constipation at Follow up
Day one, day three after surgery
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startFeb 2013
- Primary completionJan 2023
- Study completionJan 2023
Why it stopped: No enough recruitments, very slow enrollment over the years
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LaminectomyStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
- Investigators
- Roya Yumul, M.D., PhD., Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252432
- Sponsor's protocol ID
- Pro00030109
- Status last verified
- Feb 2024
- First submitted
- 26 Sep 2014
- Last updated
- 29 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Ketamine and Methadone for Laminectomy: Effect on Recovery, Postoperative Pain, and Opioid Requirements
- ClinicalTrials.gov ID
- NCT02252432
- Acronym / sponsor ID
- Pro00030109
- Conditions
- Laminectomy
- Keywords
- KETAMINE, METHADONE, POSTOPERATIVE PAIN, OPIOID REQUIREMENTS, Length of hospital stay, Perioperative outcomes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No enough recruitments, very slow enrollment over the years
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Jan 2023 (actual)
- Study completion
- Jan 2023 (actual)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Posted 29 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Active comparator | Drug: Methadone, Drug: Ketamine + methadoneA bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min)) |
| Methadone | Active comparator | Drug: Ketamine, Drug: Ketamine + methadoneWill receive a single dose of IV methadone (0.2 mg/kg) preinduction |
| Ketamine + methadone | Experimental | Drug: Ketamine, Drug: MethadoneMethadone (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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 - 80 years old of either gender, scheduled for elective lumbar laminectomy
Key exclusion criteria (26 listed)
- 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
- Increased intraocular pressure (e.g., untreated glaucoma)
- Uncontrolled hypertension (BP > 140/90)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineA bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min) | Drug | Ketamine + methadone, Methadone |
| MethadoneA single dose of IV methadone (0.2 mg/kg) preinduction. | Drug | Ketamine, Ketamine + methadone |
| Ketamine + methadoneMethadone (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, Methadone |
Primary outcome
Opioid Consumption Obtained From the Recorded Data
Time frame: 1 day
Perioperative use of opioid consumption inside the hospital (recorded by study staff and data obtained from patient charts)
Postoperative Pain
Time frame: 1 day
Postoperative pain was measured at PACU using a Verbal Rating Scale from 0 to 10. Where 0= no pain and 10= maximum pain experienced
2 secondary outcomes
Nausea and Vomiting
Time frame: 1 day
Number of Participants With Constipation at Follow up
Time frame: 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Laminectomy
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Spinal Surgery for Lumbar Spinal Stenosis (LSS)
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
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Virtual Pain Education for Spinal Cord Stimulation Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roya Yumul, M.D., PhD. principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine, Methadone and Ketamine + methadone in people with Laminectomy, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Consumption Obtained From the Recorded Data (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.