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

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

Sponsors

Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborator: Prof. Marco Rossi
Dr. Roberta Nestorini
Dr. Mariangela Di Muro

Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.

Overall Status Recruiting
Start Date May 11, 2020
Completion Date September 2020
Primary Completion Date September 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Numerical Rating Scale (NRS) at Post-Anesthesia Care Unit (PACU) arrival At the end of surgery, at PACU arrival.
Secondary Outcome
Measure 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. 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.
Length of hospital stay At discharge, an average of 48 hours from the end of surgery.
Enrollment 25
Condition
Intervention

Intervention type: Procedure

Intervention name: ESP block

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

Arm group label: ESP block

Intervention type: Procedure

Intervention name: Wound infiltration

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

Arm group label: Wound infiltration

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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Location
facility status contact Policlinico A. Gemelli Alessandro Vergari + 39 06 3015 3288 [email protected]
Location Countries

Italy

Verification Date

May 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigator full name: Alessandro Vergari

Investigator title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: ESP block

Arm group type: Experimental

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

Arm group label: Wound infiltration

Arm group type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov