Clinical trial NCT05271331: ESP Block Versus Wound Infiltration for Laminectomy
Official title: ESP Block Versus Wound Infiltration for Laminectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Opioid Use
Anesthesia, Local
Surgery
Keywords: ESP block
Laminectomy
Wound infiltration
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Tramadol consumption
timeFrame: Evaluated from extubation for the first post-operative 24 hours
Secondary outcomes:
measure: Pain 0 hours
timeFrame: At extubation
measure: Pain 6 hours
timeFrame: 6 hours after end of surgery
measure: Pain 12 hours
timeFrame: 12 hours after end of surgery
measure: Pain 24 hours
timeFrame: 24 hours after end of surgery
measure: Time to first analgesic requirement
timeFrame: 24 hours after end of surgery
measure: Incidence of post operative nausea-vomiting
timeFrame: 24 hours after end of surgery
measure: Incidence of post operative respiratory depression
timeFrame: 24 hours after end of surgery
measure: Incidence of post operative pruritus
timeFrame: 24 hours after end of surgery
measure: Incidence of post operative motor block
timeFrame: 24 hours after end of surgery
measure: Intraoperative opioid consumption
timeFrame: At extubation
measure: Evaluation of patient satisfaction
timeFrame: 24 hours after end of surgery
Other outcomes:
Locations:
city: Padova
country: Italy
facility: University Hospital of Padova
state: Veneto
Study officials:
affiliation: University Hospital of Padova
name: Federico Geraldini, MD
role: PRINCIPAL_INVESTIGATOR
References: