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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270437
• Other study ID #: CBX 726
• Status: Completed
• Phase: Phase 4
• First received: August 2, 2014
• Last updated: August 27, 2015
• Start date: June 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Testing of body temperature,routine blood examination		hospital admission and 1, 3, 5 days after the surgery	Yes
Primary	To evaluate the Morphine consumption and PCIA duration		12 hours to 3 days after the surgery	No
Secondary	To evaluate the visual analog scale (VAS) in each group patients underwent total knee arthroplasty		4 hours to 5 days after the surgery	No
Secondary	Function recovery evaluation for patients received surgery		1, 3 and 5 days after the surgery	No