Skip to main content
Clinical Trials/NCT02082067
NCT02082067
Withdrawn
Phase 4

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

ASST Gaetano Pini-CTO1 site in 1 countryMarch 2014

Overview

Phase
Phase 4
Intervention
Ropivacaine 0,75%
Conditions
Total Knee Arthroplasty
Sponsor
ASST Gaetano Pini-CTO
Locations
1
Primary Endpoint
Up and Go test
Status
Withdrawn
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
March 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
ASST Gaetano Pini-CTO
Responsible Party
Principal Investigator
Principal Investigator

Gianluca Cappelleri

Medical Doctor

ASST Gaetano Pini-CTO

Eligibility Criteria

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%

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

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

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

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

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%

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%

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

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

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

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

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

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

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

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%

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%

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%

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

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

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

Controls

No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.

Intervention: Spinal Anesthesia

Controls

No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.

Intervention: Intravenous analgesia

Controls

No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.

Intervention: Levobupivacaine 0,5%

Controls

No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.

Intervention: Ketorolac 30mg

Controls

No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.

Intervention: Morphine

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)

Study Sites (1)

Loading locations...

Similar Trials