ESP Block Versus Wound Infiltration for Laminectomy

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

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

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Anesthesia, Local; Surgery; Opioid Use
• Intervention / Treatment: Drug: Wound infiltration with saline; Drug: ESP block with local anesthetic; Drug: ESP block with saline; Drug: Wound infiltration with local anesthetic

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessandro De Cassai; Phone Number: +390498213090; Email: alessandro.decassai@gmail.com

Study Locations

• Italy
  • Veneto
    • Padova, Veneto, Italy, 35127
      • Recruiting
      • University Hospital of Padova
      • Contact: Alessandro De Cassai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESP block; Patient will receive ESP block one level above surgery with ropivacaine 0.35% 20 ml per side Patient will receive preoperative wound infiltration with Saline 40 ml	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); Other Names: Erector spinae plane block
Active Comparator: Wound infiltration; Patient will receive ESP block one level above surgery with Saline 20 ml per side Patient will receive preoperative wound infiltration with ropivacaine 0.35% 40 ml	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); Other Names: Erector spinae plane block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tramadol consumption	Postoperative tramadol consumption	Evaluated from extubation for the first post-operative 24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Padova
• Investigators: Principal Investigator: Federico Geraldini, MD, University Hospital of Padova

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Anticipated): May 20, 2023
• Study Completion (Anticipated): May 20, 2023

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: February 26, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 28, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Laminectomy; ESP block; Wound infiltration
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 5211/AO/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: IPD will be shared on reasonable request after ethical committee request examination

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No