Stimulating Catheter for Lumbar Plexus Block: Better Postoperative Analgesia?

NCT02162121 — Phase 4, Completed, 64 participants, ASST Gaetano Pini-CTO
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RegistryNCT02162121
StatusCompleted
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment64 (Actual)
SponsorASST Gaetano Pini-CTO (Other)
ConditionsHip Replacement Arthroplasty
InterventionsContinuous lumbar plexus: stimulating catheter, Spinal Anesthesia, Local anesthetic infusion, Intravenous analgesia, Opioids rescue analgesia, Mepivacaine 1%, Levobupivacaine 0,5%, Ropivacaine 0,2%, Ketorolac 30mg, Buprenorphine 0,2mg, Stimulong, Pajunk, Germany., Continuous lumbar plexus: non-stimulating catheter (Procedure, drug, device)
Datesstart 2014-05-01, primary completion 2016-10-01, completion 2016-10-01, first posted 2014-06-12, last updated 2017-08-14
Locations1 site in Italy

Related Papers Related Patents Related Grants Related Experts
All trials for Hip Replacement Arthroplasty All trials of Continuous lumbar plexus: stimulating catheter All trials of Spinal Anesthesia

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Stimulating catheterExperimentalProcedure: Continuous lumbar plexus: stimulating catheter; Procedure: Spinal Anesthesia; Procedure: Local anesthetic infusion; Procedure: Intravenous analgesia; Procedure: Opioids rescue analgesia; Drug: Mepivacaine 1%; Drug: Levobupivacaine 0,5%; Drug: Ropivacaine 0,2%; Drug: Ketorolac 30mg; Drug: Buprenorphine 0,2mg; Device: Stimulong, Pajunk, Germany.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.
Non-stimulating catheterActive comparatorProcedure: Spinal Anesthesia; Procedure: Local anesthetic infusion; Procedure: Intravenous analgesia; Procedure: Opioids rescue analgesia; 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 catheterAfter 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.
  • 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)

+Outcome measures

Primary outcomes

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

Secondary outcomes

  • Visual Analog scale (VAS) score [72h postoperatively]: Evaluation of VAS static and VAS dynamic during first 72 postoperative hours
  • Up and Go test [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
  • Opioids request [72h postoperatively]: Opioids consumption will be recorded throughout 72 postoperative hours
  • Quadriceps strength [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°.
  • postoperative nausea and vomiting (PONV) [72h postoperatively]: Evaluation of nausea and vomit incidence in postoperative period with scale 0 from 4
  • Needle redirections [During catheter position]: During catheter positioning number of needle redirections necessary to found lumbar plexus are recorder.
  • Catheter insertion time [During catheter positioning]: Time (minutes) needed for catheter placement

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* patients undergoing total hip arthroplasty

Exclusion Criteria:

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

+Locations (1)

FacilityCityCountryStatus
Istituto ortopedico Gaetano PiniMilanItaly

+Investigators