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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02799797
Other study ID # cuixulei1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2016
Est. completion date April 18, 2018

Study information

Verified date April 2019
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date April 18, 2018
Est. primary completion date February 3, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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
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
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.
rescue sulfentanil given postoperatively as PICA
bolus: 2mg, lock time: 10min, 1h limitation: 8mg

Locations

Country Name City State
China Xulei CUI Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Cui Xulei Medical Consulting Center

Country where clinical trial is conducted

China, 

Outcome

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