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

Summary

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.

Conditions

• Pain, Postoperative
• SPINAL Fracture
• Spondylolisthesis

Interventions

PROCEDURE

ESP block

ESP block bilaterally performed at the level of the surgical site prior to surgery.

PROCEDURE

Wound infiltration

Wound infiltration performed at the surgical site at the end of surgery.

Sponsors & Collaborators

• Prof. Marco Rossi

  collaborator UNKNOWN

• Dr. Roberta Nestorini

  collaborator UNKNOWN

• Dr. Mariangela Di Muro

  collaborator UNKNOWN

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-11

Primary Completion

2020-09-28

Completion

2020-09-28

Countries

• Italy

Study Locations