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Completed

NCT Number: NCT02162121

Stimulating Catheter for Lumbar Plexus Block: Better Postoperative Analgesia?

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.

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Key information

Conditions

Hip Replacement Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Istituto ortopedico Gaetano Pini

Milan, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing total hip arthroplasty

Exclusion criteria

  • diabetes neurological disorders coagulation disorders rheumatoid arthritis chronic opioids therapy allergy to local anesthetic

Treatment and study plan

Continuous lumbar plexus: stimulating catheter

Procedure

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.

Spinal anesthesia

Procedure

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

Local anesthetic infusion

Procedure

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

Intravenous analgesia

Procedure

Ketorolac 30mg 3 times a day

Opioids rescue analgesia

Procedure

Buprenorphine 0,2mg twice a day if VAS>4

Mepivacaine 1%

Drug

Levobupivacaine 0,5%

Drug

Ropivacaine 0,2%

Drug

Ketorolac 30mg

Drug

Buprenorphine 0,2mg

Drug

Stimulong, Pajunk, Germany.

Device

Continuous lumbar plexus: non-stimulating catheter

Procedure

Primary outcomes

  1. Local anesthetic consumption

    Time frame: 72h

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

Secondary outcomes

  1. Visual Analog scale (VAS) score

    Time frame: 72h postoperatively

    Evaluation of VAS static and VAS dynamic during first 72 postoperative hours

  2. Up and Go test

    Time frame: 4th postoperative day

    "up and go" test: time need to get up from a chair, walk for 3 meters, and come back to seat down on the chair

  3. Opioids request

    Time frame: 72h postoperatively

    Opioids consumption will be recorded throughout 72 postoperative hours

  4. Quadriceps strength

    Time frame: preoperative and 24h, 48h, 72h postoperatively

    evaluate bilateral muscle strength with an isometric force dynamometer to measure the force produced during a maximum voluntary isometric contraction in a lying position by the knee flex to 90°.

  5. postoperative nausea and vomiting (PONV)

    Time frame: 72h postoperatively

    Evaluation of nausea and vomit incidence in postoperative period with scale 0 from 4

  6. Needle redirections

    Time frame: During catheter position

    During catheter positioning number of needle redirections necessary to found lumbar plexus are recorder.

  7. Catheter insertion time

    Time frame: During catheter positioning

    Time (minutes) needed for catheter placement

Sponsors and collaborators

Lead sponsor

ASST Gaetano Pini-CTO

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 12, 2014
Registry last updated
Aug 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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