NCT05271331 ESP Block Versus Wound Infiltration for Laminectomy
| NCT ID | NCT05271331 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Padova |
| Condition | Pain, Postoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2022-05-23 |
| Primary Completion | 2026-05-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 112 participants in total. It began in 2022-05-23 with a primary completion date of 2026-05-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: -Planned 1 or 2 level surgical laminectomy Exclusion Criteria: * Allergy to local anesthetics * Refusal of consent * Uncompensated cardiopathies, nephropathies, liver disease or peripheral neuropathies * Hemopathies that predispose to bleeding * Gastrointestinal ulcer or bleeding * Local infection * Psychiatric or neurological disorders (except those attributed to primary disease for which intervention is planned) History of abuse (or use in the 24 hours prior to surgery) Alcohol addiction ASA \> 3
Contact & Investigator
Federico Geraldini, MD
PRINCIPAL INVESTIGATOR
University Hospital of Padova
Frequently Asked Questions
Who can join the NCT05271331 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pain, Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05271331 currently recruiting?
Yes, NCT05271331 is actively recruiting participants. Contact the research team at alessandro.decassai@gmail.com for enrollment information.
Where is the NCT05271331 trial being conducted?
This trial is being conducted at Padova, Italy.
Who is sponsoring the NCT05271331 clinical trial?
NCT05271331 is sponsored by University of Padova. The principal investigator is Federico Geraldini, MD at University Hospital of Padova. The trial plans to enroll 112 participants.