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

Phase 4

• Conditions: Acute Pain
• Interventions: Drug: Placebo; Drug: Morphine

• Registration Number: NCT02620631
• Lead Sponsor: Stony Brook University

Brief Summary

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.

Detailed Description

This is a prospective, case-controlled randomized, double-blinded, placebo-controlled study expected to enroll up to 100 patients scheduled to undergo unilateral total knee arthroplasty (TKA) under regional anesthesia (defined as intrathecal spinal + femoral nerve blockade + femoral nerve catheter for post-operative analgesia) at Stony Brook Hospital. The patients were randomized to receive either IT morphine 0.2 mg (Group 1) or placebo (Group 2) in combination with their standard-of-care spinal anesthesia. Post-operatively, the patients were given an intravenous patient-controlled analgesic opioid for breakthrough pain.

Only the pharmacist preparing the drug/placebo has knowledge of how each subject was randomized. Study staff completed multiple questionnaires regarding subjects' pain scores and patient disability from pain to assess changes between different study periods (ie. pre-operative, post-operative and follow up). Biological samples were also taken from each subject to measure and analyze differences and changes in endocannabinoid levels.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2014-02
• Status Verified: 2015-12
• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2015-12-01
• Last Update Submitted: 2015-12-01
• Study First Posted: 2015-12-03
• Last Update Posted: 2015-12-03
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects receive intrathecal injection of saline at time of spinal anesthesia
Morphine	Morphine	Subjects receive intrathecal injection of morphine sulfate 0.2mg at time of spinal anesthesia

Primary Outcome Measures

Name	Time	Method
Acute pain at rest	0-24 hours	Numerical rating scale pain scores were collected every 4 hours

Secondary Outcome Measures

Name	Time	Method
Total opioids dispensed	0-24 hours	Total dosage of opioids (in morphine equivalent doses) measured over 24 hours

Trial Locations

Locations (1)

Stony Brook University Hospital; 🇺🇸 Stony Brook, New York, United States