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

NCT ID: NCT04123106

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-11
• Study Completion Date: 2020-09-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ESP block

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

Group Type: EXPERIMENTAL

ESP block

Intervention Type: PROCEDURE

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

Wound infiltration

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

Group Type: ACTIVE_COMPARATOR

Wound infiltration

Intervention Type: PROCEDURE

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

Interventions

ESP block

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

Intervention Type: PROCEDURE

Wound infiltration

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Marco Rossi

UNKNOWN

Sponsor Role: collaborator

Dr. Roberta Nestorini

UNKNOWN

Sponsor Role: collaborator

Dr. Mariangela Di Muro

UNKNOWN

Sponsor Role: collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

VERGARI ALESSANDRO

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Policlinico A. Gemelli

Rome, , Italy

Countries

Italy

Other Identifiers

ESP01

Identifier Type: -

Identifier Source: org_study_id