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

This study has been completed.
Sponsor:
Collaborator:
Siriraj Hospital
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01364194
First received: May 31, 2011
Last updated: June 1, 2011
Last verified: May 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    Measure by Visual analog scale scores and morphine consumption


Secondary Outcome Measures:
  • Complication of Morphine consumption [ Time Frame: 96 hour post operation ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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)
Study First Received: May 31, 2011
Last Updated: June 1, 2011
Health Authority: Thailand: Ethical Committee

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

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

ClinicalTrials.gov processed this record on July 23, 2014