Clinical trial NCT02860949: Multimodal Drug Infiltration in Total Knee Arthroplasty: Is Posterior Capsular Infiltration Worth the Risk?
Official title: Multimodal Drug Infiltration in Total Knee Arthroplasty: Is Posterior Capsular Infiltration Worth the Risk? A Prospective, Double-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Keywords: Local anesthetic infiltration
Posterior capsular infiltration
Multimodal anesthesia
Knee arthroplasty
Pain control
Osteoarthritis, Knee
Lead sponsor: Thammasat University
Sponsor class: OTHER
Collaborators: name: Boontanapibul, Krit, M.D.
First posted: 2016-08-10
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The visual analogue scale (VAS) for pain
timeFrame: 24 hours after the operation
Secondary outcomes:
measure: Morphine consumption from patient controlled analgesia (PCA)
timeFrame: 24 hours after the operation
measure: The visual analogue scale (VAS) for satisfaction
timeFrame: 24 hours after the operation
Other outcomes:
Locations:
city: Pathumthani
country: Thailand
facility: Thammasat university hospital
state: Klongluang
Study officials:
affiliation: Faculty of Medicine, Thammasat university
name: Piya Pinsornsak, MD
role: PRINCIPAL_INVESTIGATOR
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