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Total Knee Prosthesis With Continuous Block of Adductor Canal and Outcome

A

ASST Gaetano Pini-CTO

Status and phase

Withdrawn
Phase 4

Conditions

Total Knee Arthroplasty

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02082067
IOGPGC05-14

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients undergoing total knee arthroplasty

Exclusion criteria

  • diabetes
  • neurological disorders
  • coagulation disorders
  • rheumatoid arthritis
  • chronic opioids therapy
  • allergy to local anesthetic

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 3 patient groups, including a placebo group

Adductor canal
Experimental group
Description:
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.
Treatment:
Procedure: Spinal Anesthesia
Drug: Morphine
Drug: Ketorolac 30mg
Drug: Levobupivacaine 0,5%
Procedure: Local anesthetic infusion
Procedure: Adductor canal
Device: stimulong sono, Pajunk, Germany
Procedure: Intravenous analgesia
Drug: Ropivacaine 0,75%
Drug: Levobupivacaine 0,125%
Femoral
Active Comparator group
Description:
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.
Treatment:
Procedure: Spinal Anesthesia
Drug: Morphine
Drug: Ketorolac 30mg
Drug: Levobupivacaine 0,5%
Procedure: Local anesthetic infusion
Device: stimulong sono, Pajunk, Germany
Procedure: Intravenous analgesia
Drug: Ropivacaine 0,75%
Procedure: Femoral
Drug: Levobupivacaine 0,125%
Controls
Placebo Comparator group
Description:
No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.
Treatment:
Procedure: Spinal Anesthesia
Drug: Morphine
Drug: Ketorolac 30mg
Drug: Levobupivacaine 0,5%
Procedure: Intravenous analgesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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