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NCT Number: NCT03249662

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

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.

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Key information

Conditions

Bilateral Total Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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%

Treatment and study plan

bupivacaine 200 mg

Procedure

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

bupivacaine 100 mg

Drug

bupivacaine 100 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration

Primary outcomes

  1. postoperative pain score

    Time frame: 0-24 hours postoperative

    Numerical rating scale at rest and movement in the first 24 hours postoperatively

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Efficacy of Pain Management in Different Concentrations of Bupivacaine in Periarticular Injection and Plasma Concentrations of Bupivacaine in Patients Undergoing Bilateral Knee Arthroplasty

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 15, 2017
Registry last updated
Sep 16, 2020

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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