Total Knee Prosthesis With Continuous Block of Adductor Canal and Outcome

Phase 4

Withdrawn

• Conditions: Total Knee Arthroplasty
• Interventions: Procedure: Adductor canal; Procedure: Femoral; Procedure: Intravenous analgesia; Procedure: Spinal Anesthesia; Procedure: Local anesthetic infusion; Drug: Ropivacaine 0,75%; Drug: Levobupivacaine 0,5%; Drug: Levobupivacaine 0,125%; Drug: Ketorolac 30mg; Drug: Morphine; Device: stimulong sono, Pajunk, Germany

• Registration Number: NCT02082067
• Lead Sponsor: ASST Gaetano Pini-CTO

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-28
• Study Start: 2014-03
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-10
• Primary Completion: 2015-09
• Study Completion: 2016-03
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-08
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adductor canal	Ropivacaine 0,75%	All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.
Femoral	Ropivacaine 0,75%	All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.
Adductor canal	Levobupivacaine 0,125%	All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.
Femoral	Ketorolac 30mg	All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.
Controls	Intravenous analgesia	No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.
Adductor canal	Adductor canal	All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.
Adductor canal	Spinal Anesthesia	All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.
Adductor canal	Local anesthetic infusion	All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.
Adductor canal	stimulong sono, Pajunk, Germany	All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.
Femoral	Femoral	All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.
Femoral	Local anesthetic infusion	All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.
Controls	Spinal Anesthesia	No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.
Femoral	Spinal Anesthesia	All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.
Adductor canal	Levobupivacaine 0,5%	All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.
Femoral	Intravenous analgesia	All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.
Adductor canal	Intravenous analgesia	All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.
Adductor canal	Ketorolac 30mg	All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.
Femoral	Levobupivacaine 0,5%	All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.
Femoral	Levobupivacaine 0,125%	All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.
Femoral	stimulong sono, Pajunk, Germany	All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.
Controls	Levobupivacaine 0,5%	No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.
Controls	Ketorolac 30mg	No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.
Adductor canal	Morphine	All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.
Femoral	Morphine	All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.
Controls	Morphine	No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.

Primary Outcome Measures

Name	Time	Method
Up and Go test	5th postoperative day	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

Secondary Outcome Measures

Name	Time	Method
VAS score	up to POD5	Evaluation of VAS static and VAS dynamic during hospital stay
Morphine request	up to POD5	Opioids consumption will be recorded throughout postoperative period
Range of motion	5th postoperative day	Physiotherapist measures the maximum active/passive range of motion
Quadriceps strength	5th postoperative day	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°.
Falling risk	5th postoperative day	Evaluation of falling risk with Berg Balance Scale

Trial Locations

Locations (1)

Istituto ortopedico Gaetano Pini; 🇮🇹 Milan, Italy