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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
ropivacaine, fentanyl, adrenaline
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring total knee arthroplasty, cocktail analgesia, morphine consumption

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

cocktail analgesia

no cocktail injection

Arm Description

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.

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

Outcomes

Primary Outcome Measures

To evaluate the Morphine consumption and PCIA duration

Secondary Outcome Measures

To evaluate the visual analog scale (VAS) in each group patients underwent total knee arthroplasty
Function recovery evaluation for patients received surgery

Full Information

First Posted
August 2, 2014
Last Updated
August 27, 2015
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02270437
Brief Title
Safety and Efficacy of Cocktail Periarticular Injection in Simultaneous Total Knee Arthroplasty
Official Title
Safety and Efficacy of Cocktail Periarticular Injection for Pain Management in Simultaneous Bilateral Total Knee Arthroplasty- A Prospective, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
total knee arthroplasty, cocktail analgesia, morphine consumption

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cocktail analgesia
Arm Type
Experimental
Arm Description
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.
Arm Title
no cocktail injection
Arm Type
No Intervention
Arm Description
The patients in the no cocktail injection group received PCIA morphine postoperatively.
Intervention Type
Drug
Intervention Name(s)
ropivacaine, fentanyl, adrenaline
Other Intervention Name(s)
Naropin, AstraZeneca
Intervention Description
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.
Primary Outcome Measure Information:
Title
To evaluate the Morphine consumption and PCIA duration
Time Frame
12 hours to 3 days after the surgery
Secondary Outcome Measure Information:
Title
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
Title
Function recovery evaluation for patients received surgery
Time Frame
1, 3 and 5 days after the surgery
Other Pre-specified Outcome Measures:
Title
Testing of body temperature,routine blood examination
Time Frame
hospital admission and 1, 3, 5 days after the surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wu Zhihong, Prof
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China

12. IPD Sharing Statement

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

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