NCT02620631

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

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)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	Morphine	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
DRUG	Placebo	Subjects receive intrathecal, preservative-free normal saline pre-operatively in conjunction with post-operative PCA morphine

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-02-01
• Completion: 2017-01-01
• First posted: 2015-12-03
• Last updated: 2015-12-03

Locations

1 site across 1 country: United States