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

NCT02620631 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2015-12-03

No results posted yet for this study

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.

Conditions

  • Acute Pain

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Syed Azim, MD · Stony Brook Medicine, Department of Anesthesia

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-02-28
Completion
2017-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02620631 on ClinicalTrials.gov