Stimulating Catheter for Lumbar Plexus Block: Better Postoperative Analgesia?

NCT02162121 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2017-08-14

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02162121 on ClinicalTrials.gov