ESP Block Versus Wound Infiltration for Laminectomy

University of Padova

Status: Enrolling

Conditions: Anesthesia, Local; Surgery; Pain, Postoperative; Opioid Use

Treatments: Drug: ESP block with local anesthetic; Drug: ESP block with saline; Drug: Wound infiltration with saline; Drug: Wound infiltration with local anesthetic

Study type: Interventional

Funder types: Other

Identifiers

NCT05271331

5211/AO/21

Details and patient eligibility

About

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

Enrollment: 112 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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112 participants in 2 patient groups

ESP block

Experimental group

Description:

Patient will receive ESP block one level above surgery with ropivacaine 0.35% 20 ml per side Patient will receive preoperative wound infiltration with Saline 40 ml

Treatment:

Drug: Wound infiltration with saline

Drug: ESP block with local anesthetic

Wound infiltration

Active Comparator group

Description:

Patient will receive ESP block one level above surgery with Saline 20 ml per side Patient will receive preoperative wound infiltration with ropivacaine 0.35% 40 ml

Treatment:

Drug: Wound infiltration with local anesthetic

Drug: ESP block with saline