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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03249662
Enrollment
60
Registered
2017-08-15
Start date
2017-09-27
Completion date
2020-09-14
Last updated
2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bilateral Total Knee Arthroplasty

Keywords

periarticular infiltration, postoperative pain management, plasma level of bupivacaine

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.

Interventions

PROCEDUREbupivacaine 200 mg

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

DRUGbupivacaine 100 mg

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

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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%

Design outcomes

Primary

MeasureTime frameDescription
postoperative pain score0-24 hours postoperativeNumerical rating scale at rest and movement in the first 24 hours postoperatively

Secondary

MeasureTime frameDescription
plasma bupivacaine level40 minutes after 1st articular infiltration, 15,30,45,60,90 minutes after 2nd periarticular infiltratioplasma bupivacaine level at 40 minutes after 1st articular infiltration, 15,30,45,60,90 minutes after 2nd periarticular infiltration
postoperative morphine consumptionfirst 24 hours and 24-48 hours postoperativelypostoperative morphine consumption at first 24 hours and 24-48 hours postoperatively
ambulation48 hours postoperativelypatient can walk with assistances within 48 hours postoperatively

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026