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Clinical Trials/NCT03249662
NCT03249662
Completed
Not Applicable

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

Mahidol University1 site in 1 country60 target enrollmentSeptember 27, 2017

Overview

Phase
Not Applicable
Intervention
bupivacaine 200 mg
Conditions
Bilateral Total Knee Arthroplasty
Sponsor
Mahidol University
Enrollment
60
Locations
1
Primary Endpoint
postoperative pain score
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 27, 2017
End Date
September 14, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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%

Arms & Interventions

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

Intervention: bupivacaine 200 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

Intervention: bupivacaine 100 mg

Outcomes

Primary Outcomes

postoperative pain score

Time Frame: 0-24 hours postoperative

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

Secondary Outcomes

  • plasma bupivacaine level(40 minutes after 1st articular infiltration, 15,30,45,60,90 minutes after 2nd periarticular infiltratio)
  • ambulation(48 hours postoperatively)
  • postoperative morphine consumption(first 24 hours and 24-48 hours postoperatively)

Study Sites (1)

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