Local Infiltration With Bupivacaine to Increase Quality of Post-operative Pain Control in Total Knee Replacement

June 1, 2011 updated by: Mahidol University

Periarticular Injection With Bupivacaine For Post-Operative Pain Control In Total Knee Replacement: A Prospective Randomized Double-Blind Controlled Trial

The purpose of this study is to evaluate the efficacy of periarticular injection with 0.25% bupivacaine for controlling pain after total knee replacement to improve the quality of post-operative care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Compare post operative pain control after total knee replacement by periarticular injection with 0.25% bupivacaine compare with 0.9% normal saline.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

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

  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Siriraj Hospital

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

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary osteoarthritis patients undergoing total knee replacement at Siriraj Hospital
  • BMI between 20-35
  • having a full understanding of the question in this trial

Exclusion Criteria:

  • allergy to NSAIDs, Acetaminophen, Bupivacaine
  • blood creatinine more than 1.5 mg/dl or creatinine clearance less than 60 mL/min
  • abnormal liver function
  • previous surgery on the knee undergoing total knee replacement
  • patient could not receive spinal anesthesia

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
Active Comparator: 0.25% Bupivacaine
Periarticular injection with 20 ml of 0.25% bupivacaine before wound closure.
Drug: 0.25% Bupivacaine
Periarticular injection with 20 ml of 0.25% bupivacaine before wound closure.
Other Names:
  • Marcaine
Placebo Comparator: 0.9% normal saline
Periarticular injection with 20 ml of 0.9% normal saline before wound closure.
Drug: 0.9% normal saline
Periarticular injection with 20 ml of 0.9% normal saline before wound closure.
Other Names:
  • Isotonic saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative pain
Time Frame: 96 hour post operation
Measure by Visual analog scale scores and morphine consumption
96 hour post operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication of Morphine consumption
Time Frame: 96 hour post operation
nausea, pruritis, urinary retention and constipation
96 hour post operation

Collaborators and Investigators

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

Sponsor

Mahidol University

Collaborators

Siriraj Hospital

Investigators

  • Principal Investigator: Keerati Chareancholvanich, MD, Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

March 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

May 31, 2011

First Submitted That Met QC Criteria

June 1, 2011

First Posted (Estimate)

June 2, 2011

Study Record Updates

Last Update Posted (Estimate)

June 2, 2011

Last Update Submitted That Met QC Criteria

June 1, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 516/2552(EC3)

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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