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

NCT02270437 | Completed Phase 4

• 1 other identifier: CBX 726
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

total knee arthroplasty; cocktail analgesia; morphine consumption

Outcome Measures

Primary Outcomes (1)

• To evaluate the Morphine consumption and PCIA duration

  12 hours to 3 days after the surgery

Secondary Outcomes (2)

• 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 Outcomes (1)

• Testing of body temperature,routine blood examination

  hospital admission and 1, 3, 5 days after the surgery

Study Arms (2)

cocktail analgesia

EXPERIMENTAL

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

no cocktail injection

NO INTERVENTION

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

Interventions

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.

Also known as: Naropin, AstraZeneca

cocktail analgesia

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with tricompartmental knee disease undergoing simultaneous bilateral TKA

You may not qualify if:

• diabetes mellitus
• neuromuscular deficit
• a known allergy to one of the drugs being injected
• a history of cardiac disease or arrhythmia requiring special monitoring

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Fentanyl; Epinephrine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Wu Zhihong, Prof

  Peking Union Medical College Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 2, 2014
• First Posted: October 21, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 28, 2015

Record last verified: 2015-08

Locations

CN (1)