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

Primary Purpose

Pain, Postoperative, SPINAL Fracture, Spondylolisthesis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ESP block
Wound infiltration
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Analgesia, Patient-Controlled, Anesthetics, Local, Pain, Postoperative

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Policlinico A. Gemelli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ESP block

Wound infiltration

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Number of Sublingual Sufentanil Tablets taken
All patients eligible will be provided with Sufentanil Sublingual Tablet System.
Safety profile (incidence of adverse events)
Report of any adverse effect (sickness, vomiting, itching, numbness, respiratory side effects, procedure-related complications,..)
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.
Length of hospital stay
Length of hospital stay after surgery

Full Information

First Posted
September 21, 2019
Last Updated
August 17, 2021
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators
Prof. Marco Rossi, Dr. Roberta Nestorini, Dr. Mariangela Di Muro
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1. Study Identification

Unique Protocol Identification Number
NCT04123106
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 11, 2020 (Actual)
Primary Completion Date
September 28, 2020 (Actual)
Study Completion Date
September 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators
Prof. Marco Rossi, Dr. Roberta Nestorini, Dr. Mariangela Di Muro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, SPINAL Fracture, Spondylolisthesis
Keywords
Analgesia, Patient-Controlled, Anesthetics, Local, Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESP block
Arm Type
Experimental
Arm Description
Ultrasound-guided, performed below erector spinae plane (ropivacaine 0.5% 20 mL each side).
Arm Title
Wound infiltration
Arm Type
Active Comparator
Arm Description
Ropivacaine 0.5% 20-40 mL, performed by surgeon.
Intervention Type
Procedure
Intervention Name(s)
ESP block
Intervention Description
ESP block bilaterally performed at the level of the surgical site prior to surgery.
Intervention Type
Procedure
Intervention Name(s)
Wound infiltration
Intervention Description
Wound infiltration performed at the surgical site at the end of surgery.
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS) at Post-Anesthesia Care Unit (PACU) arrival
Description
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.
Time Frame
At the end of surgery, at PACU arrival.
Secondary Outcome Measure Information:
Title
Difference in Pain Intensity Difference (PID) at PACU arrival, at 15 minutes, 30 minutes, 60 minutes, 2 hours, 6 hours from PACU arrival.
Description
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.
Time Frame
At the end of surgery, at PACU arrival; at 15 minutes, 30 minutes, 60 minutes, 2 hours, 6 hours from PACU arrival
Title
Difference in Sum of Pain Intensity Difference (SPID) at 12, 24, 48, 72 hours from PACU arrival.
Description
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.
Time Frame
12 hours, 24 hours, 48 hours, 72 hours from PACU arrival.
Title
Number of Sublingual Sufentanil Tablets taken
Description
All patients eligible will be provided with Sufentanil Sublingual Tablet System.
Time Frame
24 hours, 48 hours, 72 hours from PACU arrival.
Title
Safety profile (incidence of adverse events)
Description
Report of any adverse effect (sickness, vomiting, itching, numbness, respiratory side effects, procedure-related complications,..)
Time Frame
Anytime during the study.
Title
Patients satisfaction
Description
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.
Time Frame
Before discharge, an average of 48 hours from the end of surgery.
Title
Length of hospital stay
Description
Length of hospital stay after surgery
Time Frame
At discharge, an average of 48 hours from the end of surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Policlinico A. Gemelli
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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