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Efficacy of Pain Control in Different Bupivacaine Dose in Periarticular Injection in Bilateral Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03249662
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Brief Summary:

To study efficacy of postoperative pain control of different concentrations of bupivacaine for periarticular infiltration, part of multimodal analgesia, in bilateral total knee arthroplasty.

To study plasma concentration of bupivacaine in patient who received spinal anesthesia and single shot bilateral adductor canal block and periarticular infiltration with bupivacaine for safety level.


Condition or disease Intervention/treatment Phase
Bilateral Total Knee Arthroplasty Procedure: bupivacaine 200 mg Drug: bupivacaine 100 mg Not Applicable

Detailed Description:
Adequate postoperative pain control reduce postoperative morbidity, multimodal analgesia techniques is used for achieve this goal. multimodal analgesia for bilateral total knee arthroplasty are peripheral nerve block, periarticular infiltration, NSAIDs, gabapentins and others. patients undergoing bilateral total knee arthroplasty in siriraj hospital receive spinal anesthesia, single shot bilateral adductor canal block and bilateral periarticular infiltration with bupivacaine so patient receive a large dose of bupivacaine. the investigators study the efficacy of postoperative pain of reduced dose of bupivacaine for periarticular infiltration. and study plasma level of bupivacaine.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Pain Management in Different Concentrations of Bupivacaine in Periarticular Injection and Plasma Concentrations of Bupivacaine in Patients Undergoing Bilateral Knee Arthroplasty
Actual Study Start Date : September 27, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: bupivacaine 100 mg
bupivacaine 100 mg ketorolac 30 mg epinephrine 400 mcg add Normal saline solution(NSS) to 80 ml divided to two syringes for bilateral periarticular infiltration
Drug: bupivacaine 100 mg
bupivacaine 100 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration

Active Comparator: bupivacaine 200 mg
bupivacaine 200 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration
Procedure: bupivacaine 200 mg
bupivacaine 200 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration




Primary Outcome Measures :
  1. postoperative pain score [ Time Frame: 0-24 hours postoperative ]
    Numerical rating scale at rest and movement in the first 24 hours postoperatively


Secondary Outcome Measures :
  1. plasma bupivacaine level [ Time Frame: 40 minutes after 1st articular infiltration, 15,30,45,60,90 minutes after 2nd periarticular infiltratio ]
    plasma bupivacaine level at 40 minutes after 1st articular infiltration, 15,30,45,60,90 minutes after 2nd periarticular infiltration

  2. postoperative morphine consumption [ Time Frame: first 24 hours and 24-48 hours postoperatively ]
    postoperative morphine consumption at first 24 hours and 24-48 hours postoperatively

  3. ambulation [ Time Frame: 48 hours postoperatively ]
    patient can walk with assistances within 48 hours postoperatively



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged more than 18 years old
  • American society of anesthesiologists physical status classification 1-3
  • Undergoing bilateral total knee arthroplasty with spinal anesthesia and single shot bilateral adductor canal block

Exclusion Criteria:

  • Allergy to bupivacaine
  • Body weight less than 50 kilograms
  • Hepatic disease
  • Coagulopathy
  • Creatinine clearance less than 60 ml/min
  • Uncontrolled cerebrovascular disease
  • Hematocrit less than 35%

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): NCT03249662


Contacts
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Contact: sukanya dej-arkom, MD +6624197000 ext 7990 sukanyadej108@gmail.com

Locations
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Thailand
Faculty of Medicine Siriraj Hospital Recruiting
Bangkok Noi, Bangkok, Thailand, 10700
Contact: sukanya dejarkom    +664197000 ext 7990    sukanyadej108@gmail.com   
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: sukanya dej-arkom, MD Mahidol University

Publications:

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT03249662     History of Changes
Other Study ID Numbers: si111/2017
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahidol University:
periarticular infiltration
postoperative pain management
plasma level of bupivacaine
Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Epinephrine
Racepinephrine
Bupivacaine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents