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ESP Block Versus Wound Infiltration for Laminectomy

ESP Block Versus Wound Infiltration for Laminectomy: a Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05271331
Enrollment
112
Registered
2022-03-09
Start date
2022-05-23
Completion date
2026-05-20
Last updated
2025-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local, Opioid Use, Pain, Postoperative, Surgery

Keywords

ESP block, Laminectomy, Wound infiltration

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

Interventions

DRUGESP 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)

DRUGWound infiltration with saline

Blinded injection of saline in the skin, subcutaneous tissue and muscles at the site of surgical incision

DRUGESP 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)

DRUGWound 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.

Sponsors

University of Padova
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Both arms will receive the same treatment (Wound infiltration and ESP block) after general anesthesia induction (Participant masked to intervention) Drugs will be prepared after randomization by a physician not involved in the care of the patients and not involved in the study, and labelled as WOUND INFILTRATION and ESP block. One syringe will contain local anesthetic, the other normal saline (Care Provider masked to intervention, Investigator masked to intervention) Outcome assessor will be not involved in other part of the study and will be not aware of the intervention (Outcome assessor masked to intervention)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Tramadol consumptionEvaluated from extubation for the first post-operative 24 hoursPostoperative tramadol consumption

Secondary

MeasureTime frameDescription
Pain 6 hours6 hours after end of surgeryPain measured with Numeric Rating Scale (0-10)
Pain 12 hours12 hours after end of surgeryPain measured with Numeric Rating Scale (0-10)
Pain 24 hours24 hours after end of surgeryPain measured with Numeric Rating Scale (0-10)
Time to first analgesic requirement24 hours after end of surgeryTime in minutes to first analgesic requirement
Incidence of post operative nausea-vomiting24 hours after end of surgeryIncidence of post operative nausea-vomiting
Pain 0 hoursAt extubationPain measured with Numeric Rating Scale (0-10)
Incidence of post operative pruritus24 hours after end of surgeryIncidence of post operative pruritus
Incidence of post operative motor block24 hours after end of surgeryIncidence of post operative motor block
Intraoperative opioid consumptionAt extubationIntraoperative difference in consumption of fentanyl.
Evaluation of patient satisfaction24 hours after end of surgeryEvaluation of patient satisfaction of analgesia on a numeric rating score from 0-10.
Incidence of post operative respiratory depression24 hours after end of surgeryIncidence of post operative respiratory depression

Countries

Italy

Contacts

Primary ContactAlessandro De Cassai
alessandro.decassai@gmail.com+390498213090

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026