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Single Adductor-canal-block Versus Peri-articular Infiltration on Outcome After Total Knee Arthroplasty

Primary Purpose

Osteoarthritis,Knee

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
single adductor-canal-block
periarticular infiltration
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis,Knee focused on measuring knee arthroplasty, adductor canal block, periarticular infiltration

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • osteoarthritis
  • unilateral total knee arthroplasty
  • ASA grade I - II
  • normal cognitive function.

Exclusion Criteria:

  • patients refuse
  • BMI > 35
  • diagnosis other than osteoarthritis
  • allergy to the drugs used or contraindication to the intervention

Sites / Locations

  • Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

single adductor-canal-block

periarticular infiltration

Arm Description

Patients in this group will receive ultrasound guided single adductor-canal- block with 0.35% ropivacaine 25ml.

patients in this group will receive periarticular infiltration of local anesthetic.

Outcomes

Primary Outcome Measures

the time required for functional recovery
Patients are evaluated postoperatively to determine whether the patients have meet the criteria of functional recovery.The criteria of functional recovery are as followings: walking distance more than 70m with crutch, getting up or standing up independently and visual analog score less than 5 both in rest and after movement. Before discharge, patients are assessed every morning. After discharge, patients are followed up by phone every two days.

Secondary Outcome Measures

postoperative WOMAC scales
We compare the WOMAC scales of two groups before, three months, six months, and one year after the surgery.
Postoperative complications
Any complication, including nause and vomiting, deep vein thrombosis, pulmonary embolism, pulmonary infection, urinary tract infection,cardiovascular event and falls are recorded during inhospital stay.
postoperative VAS scale
Pain at rest and while moving are evaluated by a visual analog scale preoperative, 6h, 24h, 48h, 1month, 3 months and 1 year after the surgery.
postoperative morphine consumption
Consumptions of morphine are recorded at 6h, 24h, 48h after the surgery.
postoperative SF-36 score
We compare the SF-36 score of two groups before, three months,six months and one year after the surgery.

Full Information

First Posted
May 15, 2016
Last Updated
April 4, 2017
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02784041
Brief Title
Single Adductor-canal-block Versus Peri-articular Infiltration on Outcome After Total Knee Arthroplasty
Official Title
Comparison of the Effect of Single Adductor-canal-block and Peri-articular Infiltration on the Outcome After Unilateral Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the effect of single adductor-canal-block versus single femoral nerve block on the recovery after total knee arthroplasty.
Detailed Description
The aim of this study is to assess the effect of different analgesic effects on the outcome of patients undergoing total knee arthroplasty. Patients who will have primary unilateral total knee replacement between September 2016 to June 2018 at Peking Union Medical College Hospital and meet the inclusion criteria will be included. They are randomized into two groups. The total knee arthroplasty is performed by one surgeon and adductor-canal block is performed by one anesthesiologist who is not responsible for follow-up. Patients on both groups will have intravenous patient control analgesia with 1 mg morphine/bolus. One residency is responsible for the follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis,Knee
Keywords
knee arthroplasty, adductor canal block, periarticular infiltration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single adductor-canal-block
Arm Type
Experimental
Arm Description
Patients in this group will receive ultrasound guided single adductor-canal- block with 0.35% ropivacaine 25ml.
Arm Title
periarticular infiltration
Arm Type
Experimental
Arm Description
patients in this group will receive periarticular infiltration of local anesthetic.
Intervention Type
Drug
Intervention Name(s)
single adductor-canal-block
Intervention Description
Single adductor-canal-block is performed before the surgery. A 12Hz linear ultrasound transducer is placed on the medial part of the thigh with the leg slightly externally rotated. The femoral artery was identified in short axis in the adductor canal, underneath the sartorius muscle. After skin disinfection , an 18-gauge needle (B.Braun Medical, Melsungen, Germany) is inserted in-plane from the lateral side of the transducer. The needle tip was placed underneath the sartorius muscle, just lateral to the artery and saphenous nerve, using 2-3 ml of saline to ensure correct placement. 25 ml of 0.35% ropivacaine is slowly injected with repeated aspiration.
Intervention Type
Drug
Intervention Name(s)
periarticular infiltration
Intervention Description
The periarticular infiltration of multimodal agents will involve the preparation of a mixture of 100 ml solution. The mixture contains 30ml (300mg) ropivacaine, 0.5ml (5 mg) morphine, 2 ml (50 mg) flurbiprofen and 0.5 ml of 1:1000 epinephrine, and then is diluted with 0.9% normal saline to a total volume of 100ml. 50 ml of mixture will be injected into the anterior, medial and lateral soft tissues after the implantation of the joint prostheses. The remaining 50 ml of mixture will be injected into intraarticular space after the closure of articular capsule.
Primary Outcome Measure Information:
Title
the time required for functional recovery
Description
Patients are evaluated postoperatively to determine whether the patients have meet the criteria of functional recovery.The criteria of functional recovery are as followings: walking distance more than 70m with crutch, getting up or standing up independently and visual analog score less than 5 both in rest and after movement. Before discharge, patients are assessed every morning. After discharge, patients are followed up by phone every two days.
Time Frame
from the date of the surgery to the time when the patients meet the criteria of functional recovery. The earliest day on which the patient achieves the criteria of functional recovery will be recorded and the average time is 7 days after surgery.
Secondary Outcome Measure Information:
Title
postoperative WOMAC scales
Description
We compare the WOMAC scales of two groups before, three months, six months, and one year after the surgery.
Time Frame
pre-operative, three months,six months and one year afer the surgery
Title
Postoperative complications
Description
Any complication, including nause and vomiting, deep vein thrombosis, pulmonary embolism, pulmonary infection, urinary tract infection,cardiovascular event and falls are recorded during inhospital stay.
Time Frame
daily after the surgery until discharge from hospital, expected average up to 5 days after the surgery
Title
postoperative VAS scale
Description
Pain at rest and while moving are evaluated by a visual analog scale preoperative, 6h, 24h, 48h, 1month, 3 months and 1 year after the surgery.
Time Frame
pre-operative, 6h postoperative, 24h postoperative, 48h postoperative, one month postoperative, three-month postoperative, one year postoperative
Title
postoperative morphine consumption
Description
Consumptions of morphine are recorded at 6h, 24h, 48h after the surgery.
Time Frame
6h, 24h, 48h after the surgery
Title
postoperative SF-36 score
Description
We compare the SF-36 score of two groups before, three months,six months and one year after the surgery.
Time Frame
pre-operative, three months,six months and one year afer the surgery
Other Pre-specified Outcome Measures:
Title
patients' satisfaction
Description
The degree of satisfaction with surgery outcomes is assessed on a scale from fully satisfied to dissatisfied .
Time Frame
before discharge, usually 3-4 days after the surgery and one year after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: osteoarthritis unilateral total knee arthroplasty ASA grade I - II normal cognitive function. Exclusion Criteria: patients refuse BMI > 35 diagnosis other than osteoarthritis allergy to the drugs used or contraindication to the intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuguang Huang, Dr
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Single Adductor-canal-block Versus Peri-articular Infiltration on Outcome After Total Knee Arthroplasty

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