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Multimodal Drug Infiltration in Total Knee Arthroplasty: Is Posterior Capsular Infiltration Worth the Risk?

Phase 2
Completed
Conditions
Osteoarthritis, Knee
Interventions
Procedure: Drug injection at Anterior soft tissue (25 mL)+Medial gutter area (25 mL)+Lateral gutter area (25 mL)+Posterior capsular infiltration (25 mL)
Procedure: Drug injection at Anterior soft tissue (34 mL)+Medial gutter area (33 mL)+Lateral gutter area (33 mL
Registration Number
NCT02860949
Lead Sponsor
Thammasat University
Brief Summary

Multimodal local anesthetic infiltration (LAI) provides effective pain control in patients undergoing total knee arthroplasty (TKA). Some surgeons avoid posterior capsular infiltration (PCI) for fear of damaging posterior neurovascular structures. Data are limited on the added benefits of PCI using different combinations of local anesthetic agents. Therefore, the investigator wanted to know the effectiveness of pain control in LAI with and without PCI.

Half of participants received LAI with PCI, while the other half received LAI without PCI during total knee arthroplasty.

Detailed Description

Analgesic agents were bupivacaine, morphine, ketorolac and epinephrine. All patients received spinal anesthesia and patient controlled analgesia (PCA) for 24 hours post surgery. The surgical technique and postoperative medication protocols were identical in both groups. The visual analogue scale (VAS) for pain during activity and at rest, and morphine consumption were recorded at 6, 12, 18 and 24 hours postoperatively. LAI-related side effects, blood loss, length of hospital stay, and VAS for satisfaction were monitored. The reviewer was blinded to treatment groups.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
90
Inclusion Criteria
  • Primary OA of the knee, aged less than 80 years old, and able to understand and comply with the study procedures.
Exclusion Criteria
  • Previous drug dependency
  • Inability to undergo a spinal block
  • Allergy to study drugs
  • Renal insufficiency
  • Abnormal liver function
  • History of stroke
  • History of coronary artery disease

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
LAI with PCIDrug injection at Anterior soft tissue (25 mL)+Medial gutter area (25 mL)+Lateral gutter area (25 mL)+Posterior capsular infiltration (25 mL)Local anesthetic infiltration with posterior capsular injection (Drug inject at Anterior soft tissue, Medial gutter area, Lateral gutter area and Posterior capsular area)
LAI without PCI0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg mixed NSS up to 100 mLLocal anesthetic infiltration without posterior capsular injection (Drug inject at Anterior soft tissue, Medial gutter area and Lateral gutter area)
LAI without PCIDrug injection at Anterior soft tissue (34 mL)+Medial gutter area (33 mL)+Lateral gutter area (33 mLLocal anesthetic infiltration without posterior capsular injection (Drug inject at Anterior soft tissue, Medial gutter area and Lateral gutter area)
LAI with PCI0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg mixed NSS up to 100 mLLocal anesthetic infiltration with posterior capsular injection (Drug inject at Anterior soft tissue, Medial gutter area, Lateral gutter area and Posterior capsular area)
Primary Outcome Measures
NameTimeMethod
The visual analogue scale (VAS) for pain24 hours after the operation
Secondary Outcome Measures
NameTimeMethod
Morphine consumption from patient controlled analgesia (PCA)24 hours after the operation
The visual analogue scale (VAS) for satisfaction24 hours after the operation

Trial Locations

Locations (1)

Thammasat university hospital

🇹🇭

Pathumthani, Klongluang, Thailand

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