ESP Block Versus Wound Infiltration for Laminectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ESP block with saline, Wound infiltration with saline, ESP block with local anesthetic, Wound infiltration with local anesthetic.
- Who it may be relevant to
- Registry conditions: Pain, Postoperative, Opioid Use, Anesthesia, Local, Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ESP Block Versus Wound Infiltration for Laminectomy: a Randomized Controlled Trial
Overview
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
Interventions
- 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.
Primary outcome measures
- Tramadol consumption [Time frame: Evaluated from extubation for the first post-operative 24 hours]
Secondary outcome measures (11)
- Pain 0 hours [Time frame: At extubation]
- Pain 6 hours [Time frame: 6 hours after end of surgery]
- Pain 12 hours [Time frame: 12 hours after end of surgery]
- Pain 24 hours [Time frame: 24 hours after end of surgery]
- Time to first analgesic requirement [Time frame: 24 hours after end of surgery]
- Incidence of post operative nausea-vomiting [Time frame: 24 hours after end of surgery]
- Incidence of post operative respiratory depression [Time frame: 24 hours after end of surgery]
- Incidence of post operative pruritus [Time frame: 24 hours after end of surgery]
- Incidence of post operative motor block [Time frame: 24 hours after end of surgery]
- Intraoperative opioid consumption [Time frame: At extubation]
- Evaluation of patient satisfaction [Time frame: 24 hours after end of surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- University Hospital of Padova — Padova
Identifiers
NCT: NCT05271331 · 5211/AO/21