ESP Block Versus Wound Infiltration for Laminectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-23

Study Completion Date

2026-05-20

Brief Summary

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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

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Detailed Description

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Conditions

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Pain, Postoperative Opioid Use Anesthesia, Local Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Both arms will receive the same treatment (Wound infiltration and ESP block) after general anesthesia induction (Participant masked to intervention) Drugs will be prepared after randomization by a physician not involved in the care of the patients and not involved in the study, and labelled as WOUND INFILTRATION and ESP block. One syringe will contain local anesthetic, the other normal saline (Care Provider masked to intervention, Investigator masked to intervention) Outcome assessor will be not involved in other part of the study and will be not aware of the intervention (Outcome assessor masked to intervention)

Study Groups

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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

Group Type EXPERIMENTAL

Wound infiltration with saline

Intervention Type DRUG

Blinded injection of saline in the skin, subcutaneous tissue and muscles at the site of surgical incision

ESP block with local anesthetic

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

ESP block with saline

Intervention Type DRUG

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 local anesthetic

Intervention Type DRUG

Blinded injection of local anestetic (ropivacaine 0.35%, 40ml) in the skin, subcutaneous tissue and muscles at the site of surgical incision.

Interventions

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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)

Intervention Type DRUG

Wound infiltration with saline

Blinded injection of saline in the skin, subcutaneous tissue and muscles at the site of surgical incision

Intervention Type 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)

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Erector spinae plane block Erector spinae plane block

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No