Safety and Efficacy of Cocktail Periarticular Injection in Simultaneous Total Knee Arthroplasty

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: ropivacaine, fentanyl, adrenaline

Study type: Interventional

Funder types: Other

Identifiers

NCT02270437

CBX 726

Details and patient eligibility

About

We investigated the safety and efficacy of the bilateral periarticular cocktail injection at a reduced dosage in patients undergoing simultaneous bilateral total knee arthroplasty.

Full description

It is hypothesized that intraoperative periarticular injection with cocktail analgesics can reduce postoperative parenteral narcotics use and improve patient satisfaction following total knee arthroplasty.

A prospective, randomized trial is conducted to testify the hypothesis above by recruiting patients who go through simultaneous bilateral TKA and observing their postoperative analgesic consumption, visual analog scores and functional recovery. Potential side-effects of the multimodal drugs is also under observation.

Enrollment: 55 patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with tricompartmental knee disease undergoing simultaneous bilateral TKA

Exclusion criteria

• diabetes mellitus
• neuromuscular deficit
• a known allergy to one of the drugs being injected
• a history of cardiac disease or arrhythmia requiring special monitoring

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 2 patient groups

cocktail analgesia

Experimental group

Description:

The local infiltration mixture of ropivacaine, fentanyl, adrenaline is used intra-articularly during operation. The patients in the cocktail analgesia group received an injection of 200mg ropivacaine, 100ug fentanyl, and 0.25mg adrenaline into knee collateral ligaments, posterior aspect of the capsule, quadriceps tendon, patellar tendon, fat pad, periosteum, and synovium, along with PCIA morphine postoperatively.

Treatment:

Drug: ropivacaine, fentanyl, adrenaline

no cocktail injection

No Intervention group

Description:

The patients in the no cocktail injection group received PCIA morphine postoperatively.