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

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ClinicalTrials.gov Identifier: NCT02270437
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : August 28, 2015
Sponsor:
Information provided by (Responsible Party):
Zhihong Wu, 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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: ropivacaine, fentanyl, adrenaline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Cocktail Periarticular Injection for Pain Management in Simultaneous Bilateral Total Knee Arthroplasty- A Prospective, Randomized Trial
Study Start Date : June 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


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 Name: Naropin, AstraZeneca

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



Primary Outcome Measures :
  1. To evaluate the Morphine consumption and PCIA duration [ Time Frame: 12 hours to 3 days after the surgery ]

Secondary Outcome Measures :
  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 Outcome Measures:
  1. Testing of body temperature,routine blood examination [ Time Frame: hospital admission and 1, 3, 5 days after the surgery ]


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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270437


Locations
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China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100005
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Study Director: Wu Zhihong, Prof Peking Union Medical College Hospital
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Responsible Party: Zhihong Wu, Prof., Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02270437    
Other Study ID Numbers: CBX 726
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: August 28, 2015
Last Verified: August 2015
Keywords provided by Zhihong Wu, Peking Union Medical College Hospital:
total knee arthroplasty
cocktail analgesia
morphine consumption
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Epinephrine
Racepinephrine
Fentanyl
Ropivacaine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents