Stimulating Catheter for Lumbar Plexus Block: Better Postoperative Analgesia?
NCT02162121 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2017-08-14
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
- 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
Sponsors & Collaborators
-
ASST Gaetano Pini-CTO
lead OTHER
Principal Investigators
-
Gianluca Cappelleri, M.D. · ASST Gaetano Pini-CTO
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-05-31
- Primary Completion
- 2016-10-31
- Completion
- 2016-10-31
Countries
- Italy
Study Locations
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