Trials / Recruiting
RecruitingNCT05271331
ESP Block Versus Wound Infiltration for Laminectomy
ESP Block Versus Wound Infiltration for Laminectomy: a Randomized Controlled Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 112 (estimated)
- Sponsor
- University of Padova · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Spinal surgery is often burdened by perioperative pain and its treatment presently represents a challenge for anesthetists. An inadequate intra and postoperative analgesic therapy leads to a delay in the mobilization of the patients, prolonged hospital stay and thromboembolic complications, as well as the onset of chronic pain syndromes . Effective pain treatment can help improve surgical outcome for patients undergoing spinal surgery. From the pathophysiological point of view pain in vertebral surgery can originate from different anatomical structures: vertebrae, discs, ligaments, dura mater, facet joints, muscles and skin-subcutis. The terminal innervation of these tissues originate from the dorsal branches of the spinal nerves, and this represents a target a multimodal approach to perioperative analgesia in vertebral surgery. Systemically administered drugs such as NSAIDs, opioids, ketamine, intravenous lidocaine could benefit from the addition of locoregional therapies such as neuraxial blocks (anesthesia peridural or subarachnoid) or as shown more recently by other anesthesia techniques locoregional ultrasound-guided In recent years the anesthesiological interest has focused on the Erector Spinae Plane Block (ESPB). First described by Forero et al, it is a paraspinal interfascial block targeting the dorsal and ventral branches of the spinal nerves just after their emergence from the spinal cord. In the ultrasound-guided technique the local anesthetic is injected between the deep fascia of the muscle itself and the transverse processes of the vertebrae at the level interested. The aim of this study is to evaluate the efficacy of ESPB when compared to wound infiltration in patients undergoing laminectomy
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ESP block with saline | Bilateral ultrasound guided injection of saline in the erector spinae plane (below erector spinae plane muscle group and above the transverse process of the vertebra) |
| DRUG | Wound infiltration with saline | Blinded injection of saline in the skin, subcutaneous tissue and muscles at the site of surgical incision |
| DRUG | ESP block with local anesthetic | Bilateral ultrasound guided injection of local anesthetic (ropivacaine 0.35%, 40ml) in the erector spinae plane (below erector spinae plane muscle group and above the tranverse process of the vertebra) |
| DRUG | Wound infiltration with local anesthetic | Blinded injection of local anestetic (ropivacaine 0.35%, 40ml) in the skin, subcutaneous tissue and muscles at the site of surgical incision. |
Timeline
- Start date
- 2022-05-23
- Primary completion
- 2026-05-20
- Completion
- 2026-05-20
- First posted
- 2022-03-09
- Last updated
- 2025-06-26
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT05271331. Inclusion in this directory is not an endorsement.