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

NCT04123106 | Completed

• 1 other identifier: ESP01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Analgesia, Patient-Controlled; Anesthetics, Local; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale (NRS) at Post-Anesthesia Care Unit (PACU) arrival

  NRS scale is a 11-point scale (0-11), with which patients self-report and rate level of breakthrough pain, where 0 is no pain and 10 the worst pain imaginable.

  At the end of surgery, at PACU arrival.

Secondary Outcomes (6)

• Difference in Pain Intensity Difference (PID) at PACU arrival, at 15 minutes, 30 minutes, 60 minutes, 2 hours, 6 hours from PACU arrival.

  At the end of surgery, at PACU arrival; at 15 minutes, 30 minutes, 60 minutes, 2 hours, 6 hours from PACU arrival

• Difference in Sum of Pain Intensity Difference (SPID) at 12, 24, 48, 72 hours from PACU arrival.

  12 hours, 24 hours, 48 hours, 72 hours from PACU arrival.

• Number of Sublingual Sufentanil Tablets taken

  24 hours, 48 hours, 72 hours from PACU arrival.

• Safety profile (incidence of adverse events)

  Anytime during the study.

• Patients satisfaction

  Before discharge, an average of 48 hours from the end of surgery.

Study Arms (2)

ESP block

EXPERIMENTAL

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

Procedure: ESP block

Wound infiltration

ACTIVE COMPARATOR

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

Procedure: Wound infiltration

Interventions

ESP block PROCEDURE

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

ESP block

Wound infiltration PROCEDURE

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

Wound infiltration

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Prof. Marco Rossi: collaborator
• Dr. Roberta Nestorini: collaborator
• Dr. Mariangela Di Muro: collaborator

Study Sites (1)

Policlinico A. Gemelli

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative; Spinal Fractures; Spondylolisthesis; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone; Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2019
• First Posted: October 10, 2019
• Study Start: May 11, 2020
• Primary Completion: September 28, 2020
• Study Completion: September 28, 2020
• Last Updated: August 23, 2021

Record last verified: 2021-08

Locations

IT (1)