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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01364194
First Posted: June 2, 2011
Last Update Posted: June 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Siriraj Hospital
Information provided by:
Mahidol University
  Purpose
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.

Condition Intervention Phase
Pain, Postoperative Arthropathy of Knee Joint Drug: 0.25% Bupivacaine Drug: 0.9% normal saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Periarticular Injection With Bupivacaine For Post-Operative Pain Control In Total Knee Replacement: A Prospective Randomized Double-Blind Controlled Trial

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Post operative pain [ Time Frame: 96 hour post operation ]
    Measure by Visual analog scale scores and morphine consumption


Secondary Outcome Measures:
  • Complication of Morphine consumption [ Time Frame: 96 hour post operation ]
    nausea, pruritis, urinary retention and constipation


Enrollment: 60
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Isotonic saline

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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364194


Locations
Thailand
Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Siriraj Hospital
Investigators
Principal Investigator: Keerati Chareancholvanich, MD Siriraj Hospital
  More Information

Additional Information:
Publications:

Responsible Party: Keerati Chareancholvanich, MD, Siriraj Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT01364194     History of Changes
Other Study ID Numbers: 516/2552(EC3)
First Submitted: May 31, 2011
First Posted: June 2, 2011
Last Update Posted: June 2, 2011
Last Verified: May 2011

Keywords provided by Mahidol University:
Post operative pain
Total knee replacement
Total knee arthroplasty
Bupivacaine
Periarticular injection
Placebo
Morphine consumption

Additional relevant MeSH terms:
Pain, Postoperative
Joint Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Musculoskeletal Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents