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NCT Number: NCT02270437

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

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

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ropivacaine, fentanyl, adrenaline

Drug

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.

Other names: Naropin, AstraZeneca

Primary outcomes

  1. To evaluate the Morphine consumption and PCIA duration

    Time frame: 12 hours to 3 days after the surgery

Secondary outcomes

  1. To evaluate the visual analog scale (VAS) in each group patients underwent total knee arthroplasty

    Time frame: 4 hours to 5 days after the surgery

  2. Function recovery evaluation for patients received surgery

    Time frame: 1, 3 and 5 days after the surgery

Other outcomes

  1. Testing of body temperature,routine blood examination

    Time frame: hospital admission and 1, 3, 5 days after the surgery

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 21, 2014
Registry last updated
Aug 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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