Bilateral Erector Spinae Plane Block Versus Local Anesthetic Infiltration for Perioperative Analgesia in Spine Surgery.

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: SPINAL Fracture; Spondylolisthesis; Pain, Postoperative

Treatments: Procedure: Wound infiltration; Procedure: ESP block

Study type: Interventional

Funder types: Other

Identifiers

NCT04123106

ESP01

Details and patient eligibility

About

Postoperative pain still represents an important perioperative issue, affecting more than 80% of patients undergoing surgery. A suboptimal pain management doesn't just affects quality of life, but can compromise rehabilitation plan, increase morbidity and determine the development of chronic pain. Last but not least, far from being just an obligation for physicians, a good analgesia is a fundamental right of every patient.

In order to meet these important demands, a great number of guidelines has been provided, all of these underlying that the centerpiece of postoperative analgesia lies in the multimodality management, thereby combining different medications and different ways of delivering them, with the aim of targeting distinct receptor systems and improving efficacy, while limiting side effects.

In 2018, the investigators conducted a case-series analysis on 17 patients undergoing lumbar surgery to find out the role of Sublingual Sufentanil Tablet System (SSTS) in a multimodal analgesia regimen. Patients expressed a good pain relief, with most benefit during physiotherapy sessions and early discharges, in absence of side effects. Since then, SSTS has been part of regular clinical practice in our hospital.

The aim of this randomized trial is to examine the analgesic efficacy and the opioid sparing role in spine surgery of a recently developed regional anesthesia technique, the Erector Spinae Plane block (ESP block), as opposed to Local Anaesthetic (LA) wound infiltration.

The latter is a widespread, simple and unexpensive mean of providing postoperative analgesia. On the other hand, ESP block is an ultrasound-guided interfascial plain block, in which LA is injected below the erector spine muscle, closer to costotransverse foramina and origin of dorsal and ventral rami. It does provide an efficient multidermatomal sensory blockade (according to craniocaudal LA spread), with the advantage of being simple and safe.

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for lumbar fusion surgery on account of vertebral fractures or degenerative spondylolisthesis.
• Patients consent.

Exclusion criteria

• Opioid tolerance;
• Documented sleep apnoea or home oxygen therapy;
• History of alcohol or drug abuse;
• Patients with an allergy or hypersensitivity to opioids.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

ESP block

Experimental group

Description:

Ultrasound-guided, performed below erector spinae plane (ropivacaine 0.5% 20 mL each side).

Treatment:

Procedure: ESP block

Wound infiltration

Active Comparator group

Description:

Ropivacaine 0.5% 20-40 mL, performed by surgeon.

Treatment:

Procedure: Wound infiltration