Clinical trial NCT03249662: Efficacy of Pain Control in Different Bupivacaine Dose in Periarticular Injection in Bilateral Total Knee Arthroplasty
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bilateral Total Knee Arthroplasty
Keywords: periarticular infiltration
postoperative pain management
plasma level of bupivacaine
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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%

Primary outcomes:
measure: postoperative pain score
timeFrame: 0-24 hours postoperative
Secondary outcomes:
measure: plasma bupivacaine level
timeFrame: 40 minutes after 1st articular infiltration, 15,30,45,60,90 minutes after 2nd periarticular infiltratio
measure: postoperative morphine consumption
timeFrame: first 24 hours and 24-48 hours postoperatively
measure: ambulation
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Mahidol University
name: sukanya dej-arkom, MD
role: PRINCIPAL_INVESTIGATOR
References:
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