Local Anesthetic Infiltration and Infusion for Pain Control After Hip Replacement

August 3, 2011 updated by: Saint Francis Care

The Evaluation of the Efficacy of Local Infiltration Analgesia and Infusion for Total Hip Arthroplasty

The purpose of this study is to examine three different ways to control pain after hip replacement:

  1. One time injection of ropivacaine before wound closure
  2. One time injection of ropivacaine before wound closure plus slow release of ropivacaine via catheter for 48 hours
  3. Standard practice of patient controlled pump

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Saint Francis Hospital and Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • total knee replacement

Exclusion Criteria:

  • History of neurological disease, diabetes, pregnancy, allergy to local anesthetic solutions chronic narcotic use ability to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ropivacaine infiltration and infusion.
Ropivicaine infiltration followed by continuous ropivicaine infusion for 48 hours.
Procedure: Ropivacaine infiltration and infusion.
50 ml infiltration of ropivacaine 0.2% and ketorolac 15mg admixture followed by ropivacaine 0.2 % at 5ml per hour infusion for 48 hours.
Experimental: Ropivacaine and Saline
Ropivicaine infiltration followed by normal saline infusion.
Procedure: Ropivacaine infiltration and saline infusion.
50ml ropivacaine 0.2% with keterolac 15mg infiltration followed by normal saline infusion at 5ml per hour
Placebo Comparator: Saline infiltration and infusion.
Normal saline infiltration followed by saline infusion.
Procedure: Normal Saline
50ml of normal saline infiltration followed by normal saline infusion at 5ml per hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The pain medication requirement for 48 hours after surgery in three groups.
Time Frame: 48 hours after surgery
48 hours after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain scores, incidence of nausea and vomiting and patient satisfaction in each group.
Time Frame: 48 hours after surgery
48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Francis Care

Investigators

  • Principal Investigator: Sanjay Sinha, M.D., Saint Francis Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

August 2, 2011

First Submitted That Met QC Criteria

August 3, 2011

First Posted (Estimate)

August 4, 2011

Study Record Updates

Last Update Posted (Estimate)

August 4, 2011

Last Update Submitted That Met QC Criteria

August 3, 2011

Last Verified

August 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-07-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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