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Clinical Trials/NCT05271331
NCT05271331
Recruiting
Not Applicable

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

University of Padova1 site in 1 country112 target enrollmentMay 23, 2022

Overview

Phase
Not Applicable
Intervention
Wound infiltration with saline
Conditions
Pain, Postoperative
Sponsor
University of Padova
Enrollment
112
Locations
1
Primary Endpoint
Tramadol consumption
Status
Recruiting
Last Updated
10 months ago

Overview

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

Registry
clinicaltrials.gov
Start Date
May 23, 2022
End Date
May 20, 2026
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Padova
Responsible Party
Principal Investigator
Principal Investigator

Federico Geraldini

Principal Investigator

University of Padova

Eligibility Criteria

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

Arms & Interventions

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

Intervention: Wound infiltration with saline

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

Intervention: ESP block with local anesthetic

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

Intervention: ESP block with saline

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

Intervention: Wound infiltration with local anesthetic

Outcomes

Primary Outcomes

Tramadol consumption

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

Postoperative tramadol consumption

Secondary Outcomes

  • Time to first analgesic requirement(24 hours after end of surgery)
  • Pain 0 hours(At extubation)
  • Pain 12 hours(12 hours after end of surgery)
  • Evaluation of patient satisfaction(24 hours after end of surgery)
  • Incidence of post operative motor block(24 hours after end of surgery)
  • Pain 6 hours(6 hours after end of surgery)
  • Pain 24 hours(24 hours after end of surgery)
  • Incidence of post operative nausea-vomiting(24 hours after end of surgery)
  • Incidence of post operative respiratory depression(24 hours after end of surgery)
  • Incidence of post operative pruritus(24 hours after end of surgery)
  • Intraoperative opioid consumption(At extubation)

Study Sites (1)

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