ESP Block Versus Wound Infiltration for Laminectomy

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05271331
• Other study ID #: 5211/AO/21
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2022
• Est. completion date: May 20, 2023

Study information

• Verified date: May 2022
• Source: University of Padova
• Contact: Alessandro De Cassai
• Phone: +390498213090
• Email: alessandro.decassai[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: May 20, 2023
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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)
• Wound infiltration with saline
Blinded injection of saline in the skin, subcutaneous tissue and muscles at the site of surgical incision
• 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)
• 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.

Locations

Country	Name	City	State
Italy	University Hospital of Padova	Padova	Veneto

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tramadol consumption	Postoperative tramadol consumption	Evaluated from extubation for the first post-operative 24 hours
Secondary	Pain 0 hours	Pain measured with Numeric Rating Scale (0-10)	At extubation
Secondary	Pain 6 hours	Pain measured with Numeric Rating Scale (0-10)	6 hours after end of surgery
Secondary	Pain 12 hours	Pain measured with Numeric Rating Scale (0-10)	12 hours after end of surgery
Secondary	Pain 24 hours	Pain measured with Numeric Rating Scale (0-10)	24 hours after end of surgery
Secondary	Time to first analgesic requirement	Time in minutes to first analgesic requirement	24 hours after end of surgery
Secondary	Incidence of post operative nausea-vomiting	Incidence of post operative nausea-vomiting	24 hours after end of surgery
Secondary	Incidence of post operative respiratory depression	Incidence of post operative respiratory depression	24 hours after end of surgery
Secondary	Incidence of post operative pruritus	Incidence of post operative pruritus	24 hours after end of surgery
Secondary	Incidence of post operative motor block	Incidence of post operative motor block	24 hours after end of surgery
Secondary	Intraoperative opioid consumption	Intraoperative difference in consumption of fentanyl.	At extubation
Secondary	Evaluation of patient satisfaction	Evaluation of patient satisfaction of analgesia on a numeric rating score from 0-10.	24 hours after end of surgery