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Evaluation of the Use of Spinal Epimorph in Total Knee Arthroplasty

NCT01667445 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2015-04-28

No results posted yet for this study

Summary

The purpose of this study is to determine the contribution of spinal epimorph to patient's perioperative pain management in Total Knee Arthroplasty (TKA). This study is designed to determine whether spinal epimorph and its associated complications is a necessary addition to provide adequate analgesia given the multimodal approach to pain management. It is hypothesized that perioperative local infiltration with a cocktail of local and systemic analgesics will provide equal analgesia to patients who are given both local infiltration and spinal epimorph perioperatively.

Conditions

Interventions

DRUG

Epimorph

Patient to receive 150ug of Epimorph with Spinal anaesthetic. Injection Cocktail includes: 10mg Morphine, 30mg Ketorolac, 3.5ug/ml (385ug total) of Ropivicaine, 2.5ug /ml (275ug total) Epinephrine with the remainder of the solution made of Normal Saline to a total volume of 110ml.

DRUG

Spinal analgesia

Patient to receive only Spinal anaesthetic (NO EPIMORPH). Injection Cocktail includes: 10mg Morphine, 30mg Ketorolac, 3.5ug/ml (385ug total) of Ropivicaine, 2.5ug /ml (275ug total) Epinephrine with the remainder of the solution made of Normal Saline to a total volume of 110ml.

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • James L Howard, MD · London Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Canada

Study Locations

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Entities

Diseases

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 NCT01667445 on ClinicalTrials.gov