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

Multimodal Drug Infiltration in Total Knee Arthroplasty: Is Posterior Capsular Infiltration Worth the Risk? A Prospective, Double-Blind, Randomized Controlled Trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02860949

Enrollment

Registered

2016-08-10

Start date

2014-04-30

Completion date

2015-04-30

Last updated

2016-10-25

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

Conditions

Osteoarthritis, Knee

Keywords

Local anesthetic infiltration, Posterior capsular infiltration, Multimodal anesthesia, Knee arthroplasty, Pain control, Osteoarthritis, Knee

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.

Interventions

DRUG0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg mixed NSS up to 100 mL

PROCEDUREDrug injection at Anterior soft tissue (25 mL)+Medial gutter area (25 mL)+Lateral gutter area (25 mL)+Posterior capsular infiltration (25 mL)

PROCEDUREDrug injection at Anterior soft tissue (34 mL)+Medial gutter area (33 mL)+Lateral gutter area (33 mL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The visual analogue scale (VAS) for pain	24 hours after the operation

Secondary

Measure	Time frame
Morphine consumption from patient controlled analgesia (PCA)	24 hours after the operation
The visual analogue scale (VAS) for satisfaction	24 hours after the operation

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026