Clinical trial NCT04123106: Bilateral Erector Spinae Plane Block Versus Local Anesthetic Infiltration for Perioperative Analgesia in Spine Surgery.
Official title: Bilateral Erector Spinae Plane Block (ESP Block) Versus Local Anesthetic (LA) Infiltration for Perioperative Analgesia in Lumbosacral Spine Surgery: a Monocentric Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
SPINAL Fracture
Spondylolisthesis
Keywords: Analgesia, Patient-Controlled
Anesthetics, Local
Pain, Postoperative
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Prof. Marco Rossi
name: Dr. Roberta Nestorini
name: Dr. Mariangela Di Muro
First posted: 2019-10-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Numerical Rating Scale (NRS) at Post-Anesthesia Care Unit (PACU) arrival
timeFrame: At the end of surgery, at PACU arrival.
Secondary outcomes:
measure: Difference in Pain Intensity Difference (PID) at PACU arrival, at 15 minutes, 30 minutes, 60 minutes, 2 hours, 6 hours from PACU arrival.
timeFrame: At the end of surgery, at PACU arrival; at 15 minutes, 30 minutes, 60 minutes, 2 hours, 6 hours from PACU arrival
measure: Difference in Sum of Pain Intensity Difference (SPID) at 12, 24, 48, 72 hours from PACU arrival.
timeFrame: 12 hours, 24 hours, 48 hours, 72 hours from PACU arrival.
measure: Number of Sublingual Sufentanil Tablets taken
timeFrame: 24 hours, 48 hours, 72 hours from PACU arrival.
measure: Safety profile (incidence of adverse events)
timeFrame: Anytime during the study.
measure: Patients satisfaction
timeFrame: Before discharge, an average of 48 hours from the end of surgery.
measure: Length of hospital stay
timeFrame: At discharge, an average of 48 hours from the end of surgery.
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico A. Gemelli
Study officials:
References: