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

Safety and Efficacy of Cocktail Periarticular Injection for Pain Management in Simultaneous Bilateral Total Knee Arthroplasty- A Prospective, Randomized Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02270437
Enrollment
55
Registered
2014-10-21
Start date
2014-06-30
Completion date
2015-08-31
Last updated
2015-08-28

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

Conditions

Pain, Postoperative

Keywords

total knee arthroplasty, cocktail analgesia, morphine consumption

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.

Interventions

DRUGropivacaine, fentanyl, adrenaline

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.

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
To evaluate the Morphine consumption and PCIA duration12 hours to 3 days after the surgery

Secondary

MeasureTime frame
To evaluate the visual analog scale (VAS) in each group patients underwent total knee arthroplasty4 hours to 5 days after the surgery
Function recovery evaluation for patients received surgery1, 3 and 5 days after the surgery

Other

MeasureTime frame
Testing of body temperature,routine blood examinationhospital admission and 1, 3, 5 days after the surgery

Countries

China

Outcome results

None listed

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