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.

Study Overview

• Status: Completed
• Conditions: Hip Replacement Arthroplasty
• Intervention / Treatment: Procedure: 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.; Procedure: Continuous lumbar plexus: non-stimulating catheter

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • Istituto Ortopedico Gaetano Pini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients undergoing total hip arthroplasty

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stimulating catheter; 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 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.
Active Comparator: Non-stimulating catheter; 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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local anesthetic consumption	Evaluation of local anesthesic consumption every 6h in first 72 postoperative hours.	72h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog scale (VAS) score	Evaluation of VAS static and VAS dynamic during first 72 postoperative hours	72h postoperatively
Up and Go test	"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	4th postoperative day
Opioids request	Opioids consumption will be recorded throughout 72 postoperative hours	72h postoperatively
Quadriceps strength	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°.	preoperative and 24h, 48h, 72h postoperatively
postoperative nausea and vomiting (PONV)	Evaluation of nausea and vomit incidence in postoperative period with scale 0 from 4	72h postoperatively
Needle redirections	During catheter positioning number of needle redirections necessary to found lumbar plexus are recorder.	During catheter position
Catheter insertion time	Time (minutes) needed for catheter placement	During catheter positioning

Collaborators and Investigators

• Sponsor: ASST Gaetano Pini-CTO

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: June 9, 2014
• First Submitted That Met QC Criteria: June 10, 2014
• First Posted (Estimate): June 12, 2014

Study Record Updates

• Last Update Posted (Actual): August 14, 2017
• Last Update Submitted That Met QC Criteria: August 11, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Anesthetics; Buprenorphine; Ketorolac; Anesthetics, Local; Ropivacaine; Levobupivacaine; Mepivacaine
• Other Study ID Numbers: IOGPGC06-14