ESP Block Versus Wound Infiltration for Laminectomy

Not Applicable

• Conditions: Surgery; Pain, Postoperative; Opioid Use; Anesthesia, Local
• Interventions: Drug: Wound infiltration with saline; Drug: ESP block with saline; Drug: ESP block with local anesthetic; Drug: Wound infiltration with local anesthetic

• Registration Number: NCT05271331
• Lead Sponsor: University of Padova

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-02-26
• Study First Posted: 2022-03-09
• Status Verified: 2022-05
• Study Start: 2022-05-23
• Last Update Submitted: 2022-05-28
• Last Update Posted: 2022-06-01
• Primary Completion: 2023-05-20
• Study Completion: 2023-05-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESP block	ESP block with local anesthetic	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
Wound infiltration	Wound infiltration with local anesthetic	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
ESP block	Wound infiltration with saline	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
Wound infiltration	ESP block with saline	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

Primary Outcome Measures

Name	Time	Method
Tramadol consumption	Evaluated from extubation for the first post-operative 24 hours	Postoperative tramadol consumption

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Padova; 🇮🇹 Padova, Veneto, Italy