Ultrasound-guided Continuous Adductor Canal Block for Analgesia After Total Knee Replacement: Comparison of Short-axis and Long-axis Techniques

Sponsor

Cui Xulei (Other)

Overall Status

Completed

CT.gov ID

NCT02799797

Collaborator

Medical Consulting Center (Other)

Enrollment

Location

Arms

21.6

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study compares the long-axis and short-axis technique of continues adductor canal block for total knee replacement surgery. Half participants will receive long-axis catheterization, while the other half will receive short-axis catheterization.

Condition or Disease	Intervention/Treatment	Phase
Total Knee Arthroplasty Analgesia Nerve Block	Procedure: ultrasound guided long axis placement of adductor canal catheter Procedure: ultrasound guided short axis placement of adductor canal catheter Device: Philip CX 50 Ultrasound Scanner Device: PAJUNK Contiplex S Catheter Drug: Ropivocaine Drug: rescue sulfentanil given postoperatively as PICA	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Actual Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Feb 3, 2018

Actual Study Completion Date :

Apr 18, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: short axis (SAX) placement of adductor canal catheters Procedure: Ultrasound guided short axis (SAX) placement of adductor canal catheters Philip CX50 ultrasound scanner guided insertion of a PAJUNK Contiplex S catheter along the short axis of the middle part of adductor canal	Procedure: ultrasound guided short axis placement of adductor canal catheter The long axis of the ultrasound probe is placed vertical to the long axis of the adductor canal while scanning, and the catheter is placed along the short axis of the canal using an in-plane approach Device: Philip CX 50 Ultrasound Scanner The linear (C5-12) probe of Philip CX 50 Ultrasound Scanner is used for scanning Device: PAJUNK Contiplex S Catheter Drug: Ropivocaine 0.2% ropivacaine 10ml is given as loading dose. Following that, 0.2% ropivacaine 5ml/h is given as maintenance dose. Drug: rescue sulfentanil given postoperatively as PICA bolus: 2mg, lock time: 10min, 1h limitation: 8mg
Experimental: long axis (LAX) placement of adductor canal catheters Procedure: Ultrasound guided long axis (LAX) placement of adductor canal catheters Philip CX50 ultrasound scanner guided insertion of a catheter along the long axis of the middle part of adductor canal	Procedure: ultrasound guided long axis placement of adductor canal catheter The long axis of the ultrasound probe is placed parallel to the long axis of the adductor canal while scanning, and the catheter is placed along the long axis of the canal using an in-plane approach Device: Philip CX 50 Ultrasound Scanner The linear (C5-12) probe of Philip CX 50 Ultrasound Scanner is used for scanning Device: PAJUNK Contiplex S Catheter Drug: Ropivocaine 0.2% ropivacaine 10ml is given as loading dose. Following that, 0.2% ropivacaine 5ml/h is given as maintenance dose. Drug: rescue sulfentanil given postoperatively as PICA bolus: 2mg, lock time: 10min, 1h limitation: 8mg

Arm

Intervention/Treatment

Active Comparator: short axis (SAX) placement of adductor canal catheters

Procedure: Ultrasound guided short axis (SAX) placement of adductor canal catheters Philip CX50 ultrasound scanner guided insertion of a PAJUNK Contiplex S catheter along the short axis of the middle part of adductor canal

Procedure: ultrasound guided short axis placement of adductor canal catheter

The long axis of the ultrasound probe is placed vertical to the long axis of the adductor canal while scanning, and the catheter is placed along the short axis of the canal using an in-plane approach

Device: Philip CX 50 Ultrasound Scanner

The linear (C5-12) probe of Philip CX 50 Ultrasound Scanner is used for scanning

Device: PAJUNK Contiplex S Catheter

Drug: Ropivocaine

0.2% ropivacaine 10ml is given as loading dose. Following that, 0.2% ropivacaine 5ml/h is given as maintenance dose.

Drug: rescue sulfentanil given postoperatively as PICA

bolus: 2mg, lock time: 10min, 1h limitation: 8mg

Experimental: long axis (LAX) placement of adductor canal catheters

Procedure: Ultrasound guided long axis (LAX) placement of adductor canal catheters Philip CX50 ultrasound scanner guided insertion of a catheter along the long axis of the middle part of adductor canal

Procedure: ultrasound guided long axis placement of adductor canal catheter

The long axis of the ultrasound probe is placed parallel to the long axis of the adductor canal while scanning, and the catheter is placed along the long axis of the canal using an in-plane approach

Device: Philip CX 50 Ultrasound Scanner

The linear (C5-12) probe of Philip CX 50 Ultrasound Scanner is used for scanning

Device: PAJUNK Contiplex S Catheter

Drug: Ropivocaine

0.2% ropivacaine 10ml is given as loading dose. Following that, 0.2% ropivacaine 5ml/h is given as maintenance dose.

Drug: rescue sulfentanil given postoperatively as PICA

bolus: 2mg, lock time: 10min, 1h limitation: 8mg

Outcome Measures

Primary Outcome Measures

the strength of quadriceps femoris [within 48hours after surgery]
strength of quadriceps femoris measured on a Lovett muscle strength rating-scale within 48 hours after surgery

Secondary Outcome Measures

postoperative nausea and vomiting score [0-2, 2-4, 4-8, 8-24, 24-48 hours postoperative]
Rating-scale 0-3 SAX-group vs. LAX-group
ambulation time [within the 7 days after surgery]
SAX-group vs. LAX-group
quality of recovery [3days and 7days after surgery]
use the self-assessment 11item QoR scale to assess the patient's recovery quality,SAX-group vs. LAX-group
complications [within the 7 days after surgery]
Record complications including catheter dislodgment, puncture point infection, leakage,falling down,et al.
the strength of quadriceps femoris [0,2,4,8,24,48 hours postoperative]
SAX-group vs. LAX-group
Pain-score (VAS), patient at rest [0,2,4,8,24,48 hours postoperative]
Pain-score measured on a Visual Analog Scale (VAS) .SAX-group vs. LAX-group
Pain-score (VAS), motion pain [0,2,4,8,24,48 hours postoperative]
Pain-score measured on a Visual Analog Scale (VAS) .SAX-group vs. LAX-group
sulfentanil consumption [0,2,4,8,24,48 hours postoperative]
record the amount（ml) of sulfentanil used

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18-80 years
Knee-arthroscopy
Written consent
ASA I-III
BMI 19-35

Exclusion Criteria:

Unable to communicate with the investigators (e.g., a language barrier or a neuropsychiatric disorder).
coagulopathy or on anticoagulant medication
Allergic reactions toward drugs used in the trial
History of substance abuse
Infection at injection site
Can not be mobilised to 5 meters of walk pre-surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xulei CUI	Beijing	Beijing	China	100730

Sponsors and Collaborators

Cui Xulei
Medical Consulting Center

Investigators

Study Chair: Yuguang Huang, MD, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cui Xulei, Attending physician, Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT02799797

Other Study ID Numbers:

cuixulei1

First Posted:

Jun 15, 2016

Last Update Posted:

Apr 16, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Cui Xulei, Attending physician, Peking Union Medical College Hospital

adductor canal block

Additional relevant MeSH terms:

Sufentanil

Dsuvia

Study Results

No Results Posted as of Apr 16, 2019