Stimulating Catheter for Lumbar Plexus Block: Better Postoperative Analgesia?

ASST Gaetano Pini-CTO

Status and phase: Completed; Phase 4

Conditions: Hip Replacement Arthroplasty

Treatments: Device: Stimulong, Pajunk, Germany.; Drug: Ketorolac 30mg; Procedure: Opioids rescue analgesia; Procedure: Intravenous analgesia; Procedure: Spinal Anesthesia; Drug: Levobupivacaine 0,5%; Drug: Ropivacaine 0,2%; Drug: Buprenorphine 0,2mg; Drug: Mepivacaine 1%; Procedure: Continuous lumbar plexus: stimulating catheter; Procedure: Continuous lumbar plexus: non-stimulating catheter; Procedure: Local anesthetic infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT02162121

IOGPGC06-14

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing total hip arthroplasty

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

64 participants in 2 patient groups

Stimulating catheter

Experimental group

Description:

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.

Treatment:

Drug: Buprenorphine 0,2mg

Drug: Mepivacaine 1%

Procedure: Intravenous analgesia

Procedure: Spinal Anesthesia

Drug: Ketorolac 30mg

Drug: Levobupivacaine 0,5%

Procedure: Opioids rescue analgesia

Procedure: Continuous lumbar plexus: stimulating catheter

Device: Stimulong, Pajunk, Germany.

Drug: Ropivacaine 0,2%

Procedure: Local anesthetic infusion

Non-stimulating catheter

Active Comparator group

Description:

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.

Treatment:

Drug: Buprenorphine 0,2mg

Drug: Mepivacaine 1%

Procedure: Intravenous analgesia

Procedure: Spinal Anesthesia

Drug: Ketorolac 30mg

Drug: Levobupivacaine 0,5%

Procedure: Opioids rescue analgesia

Device: Stimulong, Pajunk, Germany.

Drug: Ropivacaine 0,2%

Procedure: Local anesthetic infusion

Procedure: Continuous lumbar plexus: non-stimulating catheter