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

Not Applicable

Completed

• Conditions: Bilateral Total Knee Arthroplasty
• Interventions: Drug: bupivacaine 100 mg; Procedure: bupivacaine 200 mg

• Registration Number: NCT03249662
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-12
• Study First Posted: 2017-08-15
• Study Start: 2017-09-27
• Status Verified: 2020-09
• Primary Completion: 2020-09-14
• Study Completion: 2020-09-14
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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%

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine 100 mg	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
bupivacaine 200 mg	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

Name	Time	Method
postoperative pain score	0-24 hours postoperative	Numerical rating scale at rest and movement in the first 24 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
plasma bupivacaine level	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
ambulation	48 hours postoperatively	patient can walk with assistances within 48 hours postoperatively
postoperative morphine consumption	first 24 hours and 24-48 hours postoperatively	postoperative morphine consumption at first 24 hours and 24-48 hours postoperatively

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkok Noi, Bangkok, Thailand