Total Knee Arthroplasty & Outcome: A Prospective Randomized Comparison Between Adductor Canal Block and Femoral Nerve Block
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Up and Go test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients undergoing total knee arthroplasty
Exclusion Criteria
- •neurological disorders
- •coagulation disorders
- •rheumatoid arthritis
- •chronic opioids therapy
- •allergy to local anesthetic
Arms & Interventions
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.
Intervention: Ropivacaine 0,75% (Drug)
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.
Intervention: Adductor canal (Procedure)
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.
Intervention: Spinal Anesthesia (Procedure)
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.
Intervention: Local anesthetic infusion (Procedure)
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.
Intervention: Intravenous analgesia (Procedure)
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.
Intervention: Levobupivacaine 0,5% (Drug)
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.
Intervention: Levobupivacaine 0,125% (Drug)
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.
Intervention: Ketorolac 30mg (Drug)
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.
Intervention: Morphine (Drug)
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.
Intervention: stimulong sono, Pajunk, Germany (Device)
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.
Intervention: Femoral (Procedure)
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.
Intervention: Spinal Anesthesia (Procedure)
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.
Intervention: Local anesthetic infusion (Procedure)
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.
Intervention: Intravenous analgesia (Procedure)
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.
Intervention: Ropivacaine 0,75% (Drug)
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.
Intervention: Levobupivacaine 0,5% (Drug)
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.
Intervention: Levobupivacaine 0,125% (Drug)
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.
Intervention: Ketorolac 30mg (Drug)
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.
Intervention: Morphine (Drug)
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.
Intervention: stimulong sono, Pajunk, Germany (Device)
Controls
No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.
Intervention: Spinal Anesthesia (Procedure)
Controls
No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.
Intervention: Intravenous analgesia (Procedure)
Controls
No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.
Intervention: Levobupivacaine 0,5% (Drug)
Controls
No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.
Intervention: Ketorolac 30mg (Drug)
Controls
No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.
Intervention: Morphine (Drug)
Outcomes
Primary Outcomes
Up and Go test
Time Frame: 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 Outcomes
- Falling risk(5th postoperative day)
- VAS score(up to POD5)
- Morphine request(up to POD5)
- Range of motion(5th postoperative day)
- Quadriceps strength(5th postoperative day)
Investigators
Gianluca Cappelleri
Medical Doctor
ASST Gaetano Pini-CTO