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

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: ropivacaine, fentanyl, adrenaline

• Registration Number: NCT02270437
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-08-02
• Study First Submitted QC: 2014-10-17
• Study First Posted: 2014-10-21
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-27
• Last Update Posted: 2015-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cocktail analgesia	ropivacaine, fentanyl, adrenaline	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.

Primary Outcome Measures

Name	Time	Method
To evaluate the Morphine consumption and PCIA duration	12 hours to 3 days after the surgery

Secondary Outcome Measures

Name	Time	Method
To evaluate the visual analog scale (VAS) in each group patients underwent total knee arthroplasty	4 hours to 5 days after the surgery
Function recovery evaluation for patients received surgery	1, 3 and 5 days after the surgery

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China