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

Mahidol University

Status: Completed

Conditions: Bilateral Total Knee Arthroplasty

Treatments: Drug: bupivacaine 100 mg; Procedure: bupivacaine 200 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03249662

si111/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

bupivacaine 100 mg

Experimental group

Description:

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

Treatment:

Drug: bupivacaine 100 mg

bupivacaine 200 mg

Active Comparator group

Description:

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

Treatment:

Procedure: bupivacaine 200 mg