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

• Sponsor: Peking Union Medical College Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02270437
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Jun 1, 2014
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. To evaluate the Morphine consumption and PCIA duration [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 [4 hours to 5 days after the surgery]

2. Function recovery evaluation for patients received surgery [1, 3 and 5 days after the surgery]

Other Outcome Measures

1. Testing of body temperature,routine blood examination [hospital admission and 1, 3, 5 days after the surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China	100005

Sponsors and Collaborators

• Peking Union Medical College Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhihong Wu, Prof., Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT02270437
• Other Study ID Numbers: CBX 726
• First Posted: Oct 21, 2014
• Last Update Posted: Aug 28, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Zhihong Wu, Prof., Peking Union Medical College Hospital: total knee arthroplasty; cocktail analgesia; morphine consumption
• Additional relevant MeSH terms: Pain, Postoperative; Epinephrine; Racepinephrine; Fentanyl; Ropivacaine; Epinephryl borate

Study Results

No Results Posted as of Aug 28, 2015