Overview

This trial is active, not recruiting.

Condition acute pain
Treatments morphine, placebo
Phase phase 4
Sponsor Stony Brook University
Start date March 2011
End date February 2014
Trial size 54 participants
Trial identifier NCT02620631, 200362

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Arm
(Placebo Comparator)
Subjects receive intrathecal injection of saline at time of spinal anesthesia
placebo Preservative-free normal saline
Subjects receive intrathecal, preservative-free normal saline pre-operatively in conjunction with post-operative PCA morphine
(Experimental)
Subjects receive intrathecal injection of morphine sulfate 0.2mg at time of spinal anesthesia
morphine Preservative-free morphine sulfate
Subjects receive intrathecal morphine pre-operatively to determine its level of efficacy in acute pain control post-operatively when used in conjunction with post-operative PCA morphine

Primary Outcomes

Measure
Acute pain at rest
time frame: 0-24 hours

Secondary Outcomes

Measure
Total opioids dispensed
time frame: 0-24 hours

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Prospective, Randomized, Double-blinded, Placebo-controlled Study to Examine Pain Relief and the Need for Supplementary Analgesics With Intra-thecal Morphine Sulfate (0.2 mg) in Patients Undergoing Total Knee Arthroplasty (TKA)
Principal investigator Syed Azim, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Stony Brook University.