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

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: ropivacaine, fentanyl, adrenaline

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100005
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cocktail analgesia; 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.	Drug: ropivacaine, 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.; Other Names: Naropin, AstraZeneca
No Intervention: no cocktail injection; The patients in the no cocktail injection group received PCIA morphine postoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the Morphine consumption and PCIA duration	12 hours to 3 days after the surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
Testing of body temperature,routine blood examination	hospital admission and 1, 3, 5 days after the surgery

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Director: Wu Zhihong, Prof, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: August 2, 2014
• First Submitted That Met QC Criteria: October 17, 2014
• First Posted (Estimate): October 21, 2014

Study Record Updates

• Last Update Posted (Estimate): August 28, 2015
• Last Update Submitted That Met QC Criteria: August 27, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: total knee arthroplasty; morphine consumption; cocktail analgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Fentanyl; Ropivacaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: CBX 726