Total Knee Prosthesis With Continuous Block of Adductor Canal and Outcome

Total Knee Arthroplasty Clinical Trial

Official title:

Total Knee Arthroplasty & Outcome: A Prospective Randomized Comparison Between Adductor Canal Block and Femoral Nerve Block

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02082067
• Other study ID #: IOGPGC05-14
• Status: Withdrawn
• Phase: Phase 4
• First received: February 28, 2014
• Last updated: August 8, 2016
• Start date: March 2014
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: ASST Gaetano Pini-CTO
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Aim of this study is to evaluate the effects of the adductor canal block on the early and medium term ( 1 month) rehabilitation compared to the continuous femoral block commonly used in the knee prosthesis.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing total knee arthroplasty

Exclusion Criteria:

• diabetes

• neurological disorders

• coagulation disorders

• rheumatoid arthritis

• chronic opioids therapy

• allergy to local anesthetic

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Procedure:
• Adductor canal
Perinervous catheter (stimulong sono- Pajunk, Germany) will be insert in adductor canal through tuohy needle (18G, 100mm length) under ultrasound guidance.
• Femoral
Perinervous catheter (stimulong sono- Pajunk, Germany) will be insert between femoral nerve and femoral artery through tuohy needle (18G, 100mm length) under ultrasound guidance.
• Spinal Anesthesia
Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 12mg will be injected.
• Local anesthetic infusion
Continuous infusion of levobupivacaine 0,125% at 8ml/h rate through perinervous catheter until 5th postoperative day.
• Intravenous analgesia
Ketorolac 30mg 3 times/day and morphine Patients Control Analgesia (1mg/h, max 4mg/h) administered.

Drug:
• Ropivacaine 0,75%

• Levobupivacaine 0,5%

• Levobupivacaine 0,125%

• Ketorolac 30mg

• Morphine

Device:
• stimulong sono, Pajunk, Germany

Locations

Country	Name	City	State
Italy	Istituto ortopedico Gaetano Pini	Milan

Sponsors (1)

Lead Sponsor	Collaborator
ASST Gaetano Pini-CTO

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Up and Go test	Knee functional evaluation at 5th postoperative day. "up and go" test: time need to get up from a chair, walk for 3 meters, and come back to seat down on the chair	5th postoperative day	No
Secondary	VAS score	Evaluation of VAS static and VAS dynamic during hospital stay	up to POD5	No
Secondary	Morphine request	Opioids consumption will be recorded throughout postoperative period	up to POD5	No
Secondary	Range of motion	Physiotherapist measures the maximum active/passive range of motion	5th postoperative day	No
Secondary	Falling risk	Evaluation of falling risk with Berg Balance Scale	5th postoperative day	Yes
Secondary	Quadriceps strength	evaluate muscle strength with an isometric force dynamometer to measure the force produced during a maximum voluntary isometric contraction in a lying position by the knee flex to 90°.	5th postoperative day	No