Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_4

Timeline

Completed

Started May 2014

Typical duration for phase_4

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.4 years study duration

Study Start

First participant enrolled

May 1, 2014

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

June 9, 2014

Completed

3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2014

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed

Last Updated

August 14, 2017

Status Verified

August 1, 2017

Enrollment Period

2.4 years

First QC Date

June 9, 2014

Last Update Submit

August 11, 2017

Conditions

Hip Replacement Arthroplasty

Outcome Measures

Primary Outcomes (1)

Local anesthetic consumption
Evaluation of local anesthesic consumption every 6h in first 72 postoperative hours.
72h

Secondary Outcomes (7)

Visual Analog scale (VAS) score
72h postoperatively
Up and Go test
4th postoperative day
Opioids request
72h postoperatively
Quadriceps strength
preoperative and 24h, 48h, 72h postoperatively
postoperative nausea and vomiting (PONV)
72h postoperatively
+2 more secondary outcomes

Study Arms (2)

Stimulating catheter

EXPERIMENTAL

After Spinal Anesthesia (Levobupivacaine 0,5% 15mg) all patients in the arm will receive continuous lumbar plexus block with stimulating catheter ("Stimolong", "Pajunk", Germany). Mepivacaine 1% 15 ml will be administrated. As post-operative analgesia Ropivacaine 0,2% will be continuous administrated.

Procedure: Continuous lumbar plexus: stimulating catheterProcedure: Spinal AnesthesiaProcedure: Local anesthetic infusionProcedure: Intravenous analgesiaProcedure: Opioids rescue analgesiaDrug: Mepivacaine 1%Drug: Levobupivacaine 0,5%Drug: Ropivacaine 0,2%Drug: Ketorolac 30mgDrug: Buprenorphine 0,2mgDevice: Stimulong, Pajunk, Germany.

Non-stimulating catheter

ACTIVE COMPARATOR

After Spinal Anesthesia (levobupivacaine 0,5% 15mg) all patients in the arm will receive continuous lumbar plexus block with non-stimulating catheter ("Stimolong", "Pajunk", Germany). Mepivacaine 1% 15ml will be administrated. As post-operative analgesia Ropivacaine 0,2% will be continuous administrated.

Procedure: Spinal AnesthesiaProcedure: Local anesthetic infusionProcedure: Intravenous analgesiaProcedure: Opioids rescue analgesiaDrug: Mepivacaine 1%Drug: Levobupivacaine 0,5%Drug: Ropivacaine 0,2%Drug: Ketorolac 30mgDrug: Buprenorphine 0,2mgDevice: Stimulong, Pajunk, Germany.Procedure: Continuous lumbar plexus: non-stimulating catheter

Interventions

Continuous lumbar plexus: stimulating catheterPROCEDURE

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.

Stimulating catheter

Spinal AnesthesiaPROCEDURE

Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 15mg will be injected.