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Efficacy of Multimodal Perioperative Analgesia With Periarticular Drug Injection in Total Knee Arthroplasty(TKA)

NCT01042093 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2013-11-08

Study results available
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Summary

The purpose of this study is to compare different medication combinations used in a periarticular injection after total knee replacement surgery(TKR). A periarticular injection is an injection that is given into the tissues surrounding the knee joint. The injection is given while the patient is still in surgery.

The study will compare the level of pain management, length of hospital stay, range of motion and side effects from subjects receiving one of four different combinations of medication in a periarticular injection. The medications used in the injections are approved medications routinely used for pain management.

Approximately 160 subjects will participate in this study. The surgeon, study personnel, and patients will be blinded to the combination of medications each patient receives. The pharmacist will prepare the 4 different combinations of medications, randomize each patient to the particular combination of medications, and maintain the study drug documentation.

Conditions

  • Osteoarthritis,Knee

Interventions

DRUG

Ropivacaine

Ropivacaine 5mg/ml (49.25 ml)

DRUG

Toradol

Toradol 30mg/ml (1 ml)

DRUG

Clonidine

Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)

DRUG

Epinephrine

Epinephrine 1 mg/ml (0.5 ml)

Sponsors & Collaborators

  • Towson Orthopaedic Associates

    lead OTHER

Principal Investigators

  • David F. Dalury, MD · Towson Orthpaedic Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-07-31
Completion
2011-07-31

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Entities

Drugs

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 NCT01042093 on ClinicalTrials.gov