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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

TypeNameDescription
DRUGESP block with salineBilateral ultrasound guided injection of saline in the erector spinae plane (below erector spinae plane muscle group and above the transverse process of the vertebra)
DRUGWound infiltration with salineBlinded injection of saline in the skin, subcutaneous tissue and muscles at the site of surgical incision
DRUGESP block with local anestheticBilateral 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)
DRUGWound infiltration with local anestheticBlinded 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.