University Hospital of Padova
Padova, Veneto, 35127, Italy
Location status: Recruiting
Location contact
Alessandro De Cassai, MD
CONTACT
NCT Number: NCT05271331
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Padova, Veneto, 35127, Italy
Location status: Recruiting
Alessandro De Cassai, MD
CONTACT
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
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
Blinded injection of saline in the skin, subcutaneous tissue and muscles at the site of surgical incision
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
Blinded injection of local anestetic (ropivacaine 0.35%, 40ml) in the skin, subcutaneous tissue and muscles at the site of surgical incision.
Time frame: Evaluated from extubation for the first post-operative 24 hours
Postoperative tramadol consumption
Time frame: At extubation
Pain measured with Numeric Rating Scale (0-10)
Time frame: 6 hours after end of surgery
Pain measured with Numeric Rating Scale (0-10)
Time frame: 12 hours after end of surgery
Pain measured with Numeric Rating Scale (0-10)
Time frame: 24 hours after end of surgery
Pain measured with Numeric Rating Scale (0-10)
Time frame: 24 hours after end of surgery
Time in minutes 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: At extubation
Intraoperative difference in consumption of fentanyl.
Time frame: 24 hours after end of surgery
Evaluation of patient satisfaction of analgesia on a numeric rating score from 0-10.
Contact information is provided by the study sponsor or research team.
University of Padova
Other
ESP Block Versus Wound Infiltration for Laminectomy: a Randomized Controlled Trial
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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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