Trials / Not Yet Recruiting
Not Yet RecruitingNCT07104097
Comparison Between 2 Techniques for Lumbar-ESPB
Regional Anesthesia in Hip Arthroplasty- Comparison Between Two Techniques for Erector Spinae Plane Block
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- Sponsor
- Papa Giovanni XXIII Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Diffusion of local anesthetics after a lumbar ESPB within fascial planes towards nerve structures is a matter of debate. The main objective of the study is to compare the incidence of sensory block between two techniques of needle placement (superficial or translaminar) during lumbar ESPB block. Patients are treated with lumbar ESPB (randomized to superficial or translaminar), spinal anesthesia and multimodal analgesia. The primary endpoint will be the incidence of numbness/reduced skin sensitivity to cold (ice test) in the area innervated by the lumbar plexus. Secondary outcomes are pain and analgesic's consumption, motor block, quality of recovery and discharge ability.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | spinal anesthesia | spinal anesthesia at L3-L4 plain bupivacaine 0.5% 2.2 ml |
| PROCEDURE | superficial erector spinal plane block (ESPB) | Lidocaine 1% + ropivacaine 0.25% 30 ml with adrenaline 1:200.000 on top of L3 transverse process, between bone and erector spinae muscle |
| PROCEDURE | deep (inter laminar) erector spinal plane block (ESPB) | Lidocaine 1% + ropivacaine 0.25% 30 ml with adrenaline 1:200.000 between L3 and L4 transverse process, between erector spinae muscle and deep muscles |
| DRUG | Dexamethasone | 8 mg iv preoperatively |
| DRUG | Ibuprofen 400 mg | preoperatively and postoperatively (every 8 hours) |
| DRUG | Paracetamol | 1000 mg preoperatively and postoperatively (every 8 hours) |
| DRUG | Morphine | Patient Controlled Analgesia |
Timeline
- Start date
- 2025-08-11
- Primary completion
- 2026-06-20
- Completion
- 2026-06-20
- First posted
- 2025-08-05
- Last updated
- 2025-08-11
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT07104097. Inclusion in this directory is not an endorsement.