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

NCT02784041 | Unknown DMC

• 1 other identifier: ZS-980
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis,Knee

Keywords

knee arthroplasty; adductor canal block; periarticular infiltration

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (5)

• postoperative WOMAC scales

  pre-operative, three months,six months and one year afer the surgery

• Postoperative complications

  daily after the surgery until discharge from hospital, expected average up to 5 days after the surgery

• postoperative VAS scale

  pre-operative, 6h postoperative, 24h postoperative, 48h postoperative, one month postoperative, three-month postoperative, one year postoperative

• postoperative morphine consumption

  6h, 24h, 48h after the surgery

• postoperative SF-36 score

  pre-operative, three months,six months and one year afer the surgery

Other Outcomes (1)

• patients' satisfaction

  before discharge, usually 3-4 days after the surgery and one year after the surgery

Study Arms (2)

single adductor-canal-block

EXPERIMENTAL

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

Drug: single adductor-canal-block

periarticular infiltration

EXPERIMENTAL

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

Drug: periarticular infiltration

Interventions

single adductor-canal-block DRUG

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.

single adductor-canal-block

periarticular infiltration DRUG

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.

periarticular infiltration

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Yuguang Huang, Dr

  Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2016
• First Posted: May 26, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: April 6, 2017

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)