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Completed

NCT Number: NCT01364194

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

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.

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Key information

Conditions

Pain, Postoperative Arthropathy of Knee Joint Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.25% Bupivacaine

Drug

Periarticular injection with 20 ml of 0.25% bupivacaine before wound closure.

Other names: Marcaine

0.9% normal saline

Drug

Periarticular injection with 20 ml of 0.9% normal saline before wound closure.

Other names: Isotonic saline

Primary outcomes

  1. Post operative pain

    Time frame: 96 hour post operation

    Measure by Visual analog scale scores and morphine consumption

Secondary outcomes

  1. Complication of Morphine consumption

    Time frame: 96 hour post operation

    nausea, pruritis, urinary retention and constipation

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Siriraj Hospital

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 2, 2011
Registry last updated
Jun 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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