The Effects of Ketamine and Methadone on Postoperative Pain for Laminectomy

This Phase IV interventional trial (n=13; terminated) aimed to assess the pain-reducing effects of ketamine and methadone after lumbar laminectomy (a common spinal procedure that involves partial or complete removal of the lamina from the lumbar spine to relieve compression of the neural elements within the spinal canal due to lumbar stenosis or other forms of spinal compression).

The study evaluated whether using both drugs intraoperatively could provide better pain control and reduce the need for narcotic painkillers compared to using either drug alone.

During and after surgery, patients typically require narcotics, which can lead to side effects like drowsiness and constipation, potentially delaying recovery. Ketamine and methadone were investigated as potential options to improve pain control and reduce the use of narcotic painkillers after lumbar surgery. Ketamine, an FDA-approved drug for anaesthesia, was used as an adjuvant to reduce the amount of intravenous anaesthetic drugs and minimize side effects. Methadone, also FDA-approved as an opioid pain reliever, was used intraoperatively for pain control. Both drugs were administered within the standard of care at the Cedars-Sinai Medical Center.

The trial enrolled patients aged 18 to 80 scheduled for elective lumbar laminectomy. Exclusion criteria included various health conditions and medications that could interfere with the study outcomes. The study employed a randomized, parallel assignment design with quadruple masking. The primary outcome measures included opioid consumption and postoperative pain, with secondary outcomes such as nausea, vomiting, and constipation also assessed.

The study started in February 2013 and was completed in January 2023, with actual enrollment reaching 13 participants. However, recruitment was slow over the years, leading to termination due to insufficient recruitment. The trial aimed to contribute to understanding the efficacy and safety of using ketamine and methadone intraoperatively for pain management after lumbar laminectomy.

Topic Pain
Compound Ketamine
Country United States of America
Visit trial
Status Terminated
Results Published No
Start date 01 February 2013
End date 31 January 2023
Phase Phase IV
Design Blinded
Type Interventional
Generation First
Participants 13
Sex All
Age 18- 80
Therapy No

Trial Details

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.

NCT Number NCT02252432

Sponsors & Collaborators

Cedars-Sinai Medical Center
Cedars-Sinai is a nonprofit academic healthcare organization serving the diverse Los Angeles community and beyond.

Data attribution

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