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

Bilateral Erector Spinae Plane Block (ESP Block) Versus Local Anesthetic (LA) Infiltration for Perioperative Analgesia in Lumbosacral Spine Surgery: a Monocentric Randomized Trial.

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Spondylolisthesis; SPINAL Fracture
• Intervention / Treatment: Procedure: ESP block; Procedure: Wound infiltration

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Policlinico A. Gemelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESP block; Ultrasound-guided, performed below erector spinae plane (ropivacaine 0.5% 20 mL each side).	Procedure: ESP block; ESP block bilaterally performed at the level of the surgical site prior to surgery.
Active Comparator: Wound infiltration; Ropivacaine 0.5% 20-40 mL, performed by surgeon.	Procedure: Wound infiltration; Wound infiltration performed at the surgical site at the end of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Pain Intensity Difference (PID) at PACU arrival, at 15 minutes, 30 minutes, 60 minutes, 2 hours, 6 hours from PACU arrival.	PID summarizes treatment response over a clinically relevant period. It represents a raw difference in pain intensity (i.e. the difference between the NRS value at each time point from the NRS at PACU arrival) and it is based on NRS data. It ranges from 0 to 10. The higher the value, the better the pain relief, since the greater is the pain intensity difference.	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.	SPID is calculated multiplying the PID score at each time point by the duration (in hours) since the preceding time point, and then summing the values over the relevant time period. SPID represents the sum of the absolute difference in pain intensity. It ranges from 0 to an undefined value, variable according to the time weighted sum. The higher the value, the better the pain relief, since the greater is the pain intensity difference.	12 hours, 24 hours, 48 hours, 72 hours from PACU arrival.
Number of Sublingual Sufentanil Tablets taken	All patients eligible will be provided with Sufentanil Sublingual Tablet System.	24 hours, 48 hours, 72 hours from PACU arrival.
Safety profile (incidence of adverse events)	Report of any adverse effect (sickness, vomiting, itching, numbness, respiratory side effects, procedure-related complications,..)	Anytime during the study.
Patients satisfaction	All patients will fill out an Ease-Of-Care (EOC) Questionnaire, highlighting satisfaction with level of pain control and satisfaction with method of administration of pain medication.	Before discharge, an average of 48 hours from the end of surgery.
Length of hospital stay	Length of hospital stay after surgery	At discharge, an average of 48 hours from the end of surgery.

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Collaborators: Prof. Marco Rossi; Dr. Roberta Nestorini; Dr. Mariangela Di Muro

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2020
• Primary Completion (Actual): September 28, 2020
• Study Completion (Actual): September 28, 2020

Study Registration Dates

• First Submitted: September 21, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Anesthetics, Local; Pain, Postoperative; Analgesia, Patient-Controlled
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Injuries; Back Injuries; Spondylolysis; Spondylosis; Pain, Postoperative; Spinal Fractures; Spondylolisthesis
• Other Study ID Numbers: ESP01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No