Study to Examine Pain Relief With Supplemental Intrathecal Morphine in TKA Patients

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Acute Pain

In brief

This is a prospective, randomized, double-blinded, placebo-controlled study designed to examine pain relief following intrathecal morphine sulfate (0.2mg) in patients undergoing total knee arthroplasty (TKA) under spinal anesthesia in addition to a femoral nerve catheter. The protocol consists of two parts: (1) a prospective patient recruitment study and (2) a retrospective assay for endocannabinoids on previously collected specimens.

Key facts

Study ID

NCT02620631

Run by

Stony Brook University

People needed

54

Starts

2011-03-01

Expected to finish

2017-01-01

Last updated by the study team

2015-12-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Scheduled for unilateral TKA under regional anesthesia
• ASA Class 1, 2 or 3
• Able to give informed consent
• Able to understand English

You may not qualify if…

• Medical condition(s) that prevents use of regional anesthesia (e.g. infection at site of injection, coagulopathy, severe hypovolemia, severe aortic or mitral stenosis, increased intracranial pressure, severe spinal deformity, spinal cord hardware or stimulator implanted)
• Allergy to morphine
• Morbid obesity (BMI > 45)
• Respiratory compromise (difficult airway, severe emphysema or COPD)
• Obstructive sleep apnea (only if diagnosed in a sleep disorders clinic and CPAP was prescribed)
• Chronic pain with opioid usage over 100 mg morphine-equivalents po/day
• History of abuse of opioids or other drugs of abuse
• Scheduled for bilateral TKA
• Revision of knee arthroplasty
• Any medical condition that would affect the patient's ability to metabolize or excrete the study drugs (e.g. chronic kidney failure with patient on dialysis) or other medical condition that in the investigator's opinion would render the patient unsuitable for this research study

Where it is running

• Stony Brook University Hospital — Stony Brook, New York, United States

Full record on ClinicalTrials.gov

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