NCT02162121

Stimulating Catheter for Lumbar Plexus Block: Better Postoperative Analgesia?

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: ASST Gaetano Pini-CTO · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Stimulating catheters have been introduced to reduce the incidence of secondary failure after continuous peripheral nerve blocks, but they effectiveness over traditional nonstimulating catheters is still controversial. The aim of this prospective, randomized, blinded study is to detect if stimulating catheters improve postoperative compared with conventional non-stimulating catheters.

Conditions

• Hip Replacement Arthroplasty

Interventions

Type	Name	Description
PROCEDURE	Continuous lumbar plexus: stimulating catheter	Perinervous stimulating catheter ("Stimulong", "Pajunk", Germany) will be insert in lumbar plexus through tuohy needle (18G, 100mm length). 15ml mepivacaine 1% are injected before the complete resolution of the spinal anesthesia.
PROCEDURE	Spinal Anesthesia	Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 15mg will be injected.
PROCEDURE	Local anesthetic infusion	Continuous infusion (Mini Rythmic Evolution, Micrel) of ropivacaine 0,2% at 3ml/h, bolus 3 ml, lockout time 15 min, 12 ml/h maximum dose through perinervous catheter until 3rd postoperative day
PROCEDURE	Intravenous analgesia	Ketorolac 30mg 3 times a day
PROCEDURE	Opioids rescue analgesia	Buprenorphine 0,2mg twice a day if VAS\>4
DRUG	Mepivacaine 1%
DRUG	Levobupivacaine 0,5%
DRUG	Ropivacaine 0,2%
DRUG	Ketorolac 30mg
DRUG	Buprenorphine 0,2mg
DEVICE	Stimulong, Pajunk, Germany.
PROCEDURE	Continuous lumbar plexus: non-stimulating catheter

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2014-06-12
• Last updated: 2017-08-14

Locations

1 site across 1 country: Italy