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NCT Number: NCT05271331

ESP Block Versus Wound Infiltration for Laminectomy

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Padova

Padova, Veneto, 35127, Italy

Location status: Recruiting

Location contact

Alessandro De Cassai, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESP block with saline

Drug

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)

Other names: Erector spinae plane block

Wound infiltration with saline

Drug

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

ESP block with local anesthetic

Drug

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)

Other names: Erector spinae plane block

Wound infiltration with local anesthetic

Drug

Blinded injection of local anestetic (ropivacaine 0.35%, 40ml) in the skin, subcutaneous tissue and muscles at the site of surgical incision.

Primary outcomes

  1. Tramadol consumption

    Time frame: Evaluated from extubation for the first post-operative 24 hours

    Postoperative tramadol consumption

Secondary outcomes

  1. Pain 0 hours

    Time frame: At extubation

    Pain measured with Numeric Rating Scale (0-10)

  2. Pain 6 hours

    Time frame: 6 hours after end of surgery

    Pain measured with Numeric Rating Scale (0-10)

  3. Pain 12 hours

    Time frame: 12 hours after end of surgery

    Pain measured with Numeric Rating Scale (0-10)

  4. Pain 24 hours

    Time frame: 24 hours after end of surgery

    Pain measured with Numeric Rating Scale (0-10)

  5. Time to first analgesic requirement

    Time frame: 24 hours after end of surgery

    Time in minutes to first analgesic requirement

  6. Incidence of post operative nausea-vomiting

    Time frame: 24 hours after end of surgery

    Incidence of post operative nausea-vomiting

  7. Incidence of post operative respiratory depression

    Time frame: 24 hours after end of surgery

    Incidence of post operative respiratory depression

  8. Incidence of post operative pruritus

    Time frame: 24 hours after end of surgery

    Incidence of post operative pruritus

  9. Incidence of post operative motor block

    Time frame: 24 hours after end of surgery

    Incidence of post operative motor block

  10. Intraoperative opioid consumption

    Time frame: At extubation

    Intraoperative difference in consumption of fentanyl.

  11. Evaluation of patient satisfaction

    Time frame: 24 hours after end of surgery

    Evaluation of patient satisfaction of analgesia on a numeric rating score from 0-10.

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro De Cassai

CONTACT

[email protected]

+390498213090

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2022
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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