Skip to main content
OpenTrials
Completed

NCT Number: NCT04123106

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico A. Gemelli

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ESP block

Procedure

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

Wound Infiltration

Procedure

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

Primary outcomes

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

    Time frame: At the end of surgery, at 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.

Secondary outcomes

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

    Time frame: At the end of surgery, 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.

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

    Time frame: 12 hours, 24 hours, 48 hours, 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.

  3. Number of Sublingual Sufentanil Tablets taken

    Time frame: 24 hours, 48 hours, 72 hours from PACU arrival.

    All patients eligible will be provided with Sufentanil Sublingual Tablet System.

  4. Safety profile (incidence of adverse events)

    Time frame: Anytime during the study.

    Report of any adverse effect (sickness, vomiting, itching, numbness, respiratory side effects, procedure-related complications,..)

  5. Patients satisfaction

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

    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.

  6. Length of hospital stay

    Time frame: At discharge, an average of 48 hours from the end of surgery.

    Length of hospital stay after surgery

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • Dr. Mariangela Di Muro
  • Dr. Roberta Nestorini
  • Prof. Marco Rossi

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 10, 2019
Registry last updated
Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.