Regional Anesthesia for Knee Prothesis Surgery

Total Knee Replacement Clinical Trial

Official title:

Regional Blockade for Knee Prothesis Surgery: Comparison Between Femoral, Sciatic and Adductor Canal Block

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02451605
• Other study ID #: 2014-000677-39
• Status: Not yet recruiting
• Phase: N/A
• First received: May 12, 2015
• Last updated: May 21, 2015
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: May 2015
• Source: University Hospital of Liege
• Contact: Pierre Goffin
• Phone: 003243667178
• Email: goffin.pjc[@]gmail.com
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

Comparison of the analgesics blocks (femoral, adductor canal and sciatic subgluteal nerve) for total replacement knee surgery.

Description:

Adductor canal block shows a beneficial effect for knee surgery. Mainly because he prevent for muscular weakness; adverse effect meet with femoral block and delaying the early active mobilization.

The investigators want to compare the efficacy and safety of this block compared to the femoral and sciatic block.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients scheduled for total knee replacement surgery.

Exclusion Criteria:

• refusal to study,

• coagulation disorder,

• infection at the puncture site,

• preexisting neuropathy,

• allergy to local anesthetics,

• renal or hepatocellular insufficiency,

• context of chronic pain,

• drugs abuse,

• pregnant patient.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Drug:
• Analgesic nerve blockade (Ropivacaine)
Analgesic nerve blockade (Ropivacaine) for total knee replacement surgery.

Procedure:
• Total knee replacement surgery.
Total knee replacement surgery.

Locations

Country	Name	City	State
Belgium	University og Liege, University Hospital	Liege

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain measurement with numeric pain scale : from 0 to 10 (maximal pain) in rest condition	Pain assessment and evolution in postoperative period (passive condition)	up to day 7	Yes
Primary	Pain measurement with numeric pain scale (from 0 to 10) during active motorized mobilization (Kinetic)	Pain assessment and evolution in postoperative period (active condition)	up to day 7	Yes
Secondary	Postintervention nausea vomiting	question : present or not	at hour 0, at hours 6, at day 1	Yes
Secondary	Patient satisfaction	Questionnaire of patient felling and satisfaction. Choice within gradual felling : bad, middle, good, excellent	at day 1	Yes
Secondary	Opioid consumption	doses of piritramid (synthetic opioid) administrated with patient control rescue analgesia device.	up to 48 hours	Yes