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Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery

Primary Purpose

Scoliosis, Regional Anesthesia, Pediatric Anesthesia

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Ropivacaine 0.2% Injectable Solution
Normal saline 0.9% Injectable Solution
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis focused on measuring erector spine plane block, neuromonitoring, pain management, multimodal analgesia

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients < 18 years old undergoing scoliosis surgery Exclusion Criteria: refusal to participate > 18 yo Chronic opioid use localized infection

Sites / Locations

  • Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, PolandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ESB block

Placebo block

Arm Description

Patients will receive preoperative ultrasound-guided bilateral single-injection ESP blocks at one or two levels before incision with 10 mL 0.2% ropivacaine per single injection. Using appropriate sterile precautions, under general anesthesia, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the erector spine, transverse process, and paravertebral space. A 22G 0,7x80 mm echogenic block needle (Stimuplex Ultra 360)) is inserted in-plane from the cranial to caudal direction until the needle tip contacts the transverse process. 1-3mL is injected to confirm the proper injection plane by visualizing the spread deep to the erector spinae muscles and superficial to the transverse process. Block is completed with 10mL of 0,2% Ropivacaine. The needle is withdrawn, and the needle entry site is wiped clean.

Patients will receive preoperative ultrasound-guided bilateral single-injection ESP blocks at one or two levels before incision with 10 mL 0,9% normal saline per single injection. Using appropriate sterile precautions, under general anesthesia, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the erector spine, transverse process, and paravertebral space. A 22G 0,7x80 mm echogenic block needle (Stimuplex Ultra 360)) is inserted in-plane from the cranial to caudal direction until the needle tip contacts the transverse process. 1-3mL is injected to confirm the proper injection plane by visualizing the spread deep to the erector spinae muscles and superficial to the transverse process. Block is completed with 10mL of 0,9% normal saline. The needle is withdrawn, and the needle entry site is wiped clean.

Outcomes

Primary Outcome Measures

pain score
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
pain score - 60 minutes
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
pain score - 90 minutes
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
pain score - 120 minutes
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
pain score - 6 hours
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
pain score - 12 hours
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
pain score - 24 hours
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
pain score - 48 hours
NRS (numerical rating scale) score (0- no pain to 10 worst pain)

Secondary Outcome Measures

total opioid consumption within first 24 hours
Total morphine milligram equivalents required by patients in the post-anesthesia care unit, prior to discharge from the outpatient surgery center. Following emergence from anesthesia, pain will be assessed in regular intervals, with administration of IV and oral opioids according to numeric rating scale and clinical assessment. Opioid administration stops when patient numerical rating score is <4, when patient endorses manageable pain level, when side effects of opioids are intolerable, or for other concerning clinical conditions as determined by the anesthesiologist of record.
opioid consumption - 48 hours
Total morphine milligram equivalents required by patients in the post-anesthesia care unit, prior to discharge from the outpatient surgery center. Following emergence from anesthesia, pain will be assessed in regular intervals, with administration of IV and oral opioids according to numeric rating scale and clinical assessment. Opioid administration stops when patient numerical rating score is <4, when patient endorses manageable pain level, when side effects of opioids are intolerable, or for other concerning clinical conditions as determined by the anesthesiologist of record.
Nausea and Vomiting
This is a yes/no binary outcome measure defined by administration of any antiemetic drug in the post-anesthesia care unit.
NLR -12 hours
neutrophil/limphocyte ratio
PLR -12 hours
platelet/limphocyte ratio
NLR - 24 hours
neutrophil/limphocyte ratio
PLR - 24 hours
platelet/limphocyte ratio

Full Information

First Posted
February 19, 2023
Last Updated
July 5, 2023
Sponsor
Poznan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05944393
Brief Title
Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery
Official Title
Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poznan University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Postoperative pain after scoliosis correction surgery is severe and usually requires long-term intravenous opioid therapy. Local anesthetic options are limited and include intrathecal opioids and epidural analgesia. However, they are rarely used due to side effects and inconsistent efficacy. The investigators describe an opioid-sparing multimodal analgesia regimen with bilateral erector spinae plane blocks.
Detailed Description
Posterior spinal fusion for scoliosis correction is extremely painful and usually requires long-term, high-dose opioid use for adequate perioperative analgesia. Neuromonitoring, i.e., motor-evoked and somatosensory-evoked potentials (SSEPs), are the current gold standard for preventing neurological damage. Local anesthesia is essential to multimodal analgesia, but options are limited. Intrathecal or epidural opioid injections of local anesthetics have been reported but are rarely used due to logistical complexity, side effects, and inconsistent analgesic efficacy. The erector spinae plane (ESP) block was first described in 2016 for thoracic neuropathic pain. It is a new interfacial plane technique. Easy to perform on patients without spinal deformities. It was successfully used for surgery in adults. However, even with ultrasound guidance, identifying bone markers in scoliosis patients is challenging. The investigators will treat patients for scoliosis with single-shot bilateral ESP blocks. The investigators aim to provide effective perioperative pain control and achieve intraoperative hemodynamic stability without compromising neuromonitoring.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis, Regional Anesthesia, Pediatric Anesthesia, Orthopedic Disorder of Spine
Keywords
erector spine plane block, neuromonitoring, pain management, multimodal analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
after being informed about the study and potential risks. All patients giving written consent will be randomized in a double-blind manner into 2 groups each one containing 25 patients, ESP group (n =25 ): The patients will receive Erector Spine Plane Block (ESP Block) after induction of general anesthesia. Control group (n =25 ): The patients will receive a placebo block after induction of general anesthesia
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Subjects will be randomized to one of two groups with a computer-generated arm assignment. The sealed envelopes will be opened immediately prior to nerve block. One group will receive a ESP block and the other will receive a placebo block. The provider performing the block will not be blinded, however all other members of the care team, the patient, and the investigator collecting data will be blinded to the randomization.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESB block
Arm Type
Experimental
Arm Description
Patients will receive preoperative ultrasound-guided bilateral single-injection ESP blocks at one or two levels before incision with 10 mL 0.2% ropivacaine per single injection. Using appropriate sterile precautions, under general anesthesia, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the erector spine, transverse process, and paravertebral space. A 22G 0,7x80 mm echogenic block needle (Stimuplex Ultra 360)) is inserted in-plane from the cranial to caudal direction until the needle tip contacts the transverse process. 1-3mL is injected to confirm the proper injection plane by visualizing the spread deep to the erector spinae muscles and superficial to the transverse process. Block is completed with 10mL of 0,2% Ropivacaine. The needle is withdrawn, and the needle entry site is wiped clean.
Arm Title
Placebo block
Arm Type
Experimental
Arm Description
Patients will receive preoperative ultrasound-guided bilateral single-injection ESP blocks at one or two levels before incision with 10 mL 0,9% normal saline per single injection. Using appropriate sterile precautions, under general anesthesia, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the erector spine, transverse process, and paravertebral space. A 22G 0,7x80 mm echogenic block needle (Stimuplex Ultra 360)) is inserted in-plane from the cranial to caudal direction until the needle tip contacts the transverse process. 1-3mL is injected to confirm the proper injection plane by visualizing the spread deep to the erector spinae muscles and superficial to the transverse process. Block is completed with 10mL of 0,9% normal saline. The needle is withdrawn, and the needle entry site is wiped clean.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.2% Injectable Solution
Intervention Description
Ultrasound-guided Erector Spine Plane block with 10 mL 0.5% ropivacaine
Intervention Type
Drug
Intervention Name(s)
Normal saline 0.9% Injectable Solution
Intervention Description
Ultrasound-guided Erector Spine Plane block with 10 mL 0.9% normal saline
Primary Outcome Measure Information:
Title
pain score
Description
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
Time Frame
Within 30 minutes of emergence from anesthesia
Title
pain score - 60 minutes
Description
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
Time Frame
Within 60 minutes of emergence from anesthesia
Title
pain score - 90 minutes
Description
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
Time Frame
Within 90 minutes of emergence from anesthesia
Title
pain score - 120 minutes
Description
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
Time Frame
Within 120 minutes of emergence from anesthesia
Title
pain score - 6 hours
Description
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
Time Frame
Within 6 hours of emergence from anesthesia
Title
pain score - 12 hours
Description
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
Time Frame
Within 12 hours of emergence from anesthesia
Title
pain score - 24 hours
Description
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
Time Frame
Within 24 hours of emergence from anesthesia
Title
pain score - 48 hours
Description
NRS (numerical rating scale) score (0- no pain to 10 worst pain)
Time Frame
Within 48 hours of emergence from anesthesia
Secondary Outcome Measure Information:
Title
total opioid consumption within first 24 hours
Description
Total morphine milligram equivalents required by patients in the post-anesthesia care unit, prior to discharge from the outpatient surgery center. Following emergence from anesthesia, pain will be assessed in regular intervals, with administration of IV and oral opioids according to numeric rating scale and clinical assessment. Opioid administration stops when patient numerical rating score is <4, when patient endorses manageable pain level, when side effects of opioids are intolerable, or for other concerning clinical conditions as determined by the anesthesiologist of record.
Time Frame
Second day following the procedure
Title
opioid consumption - 48 hours
Description
Total morphine milligram equivalents required by patients in the post-anesthesia care unit, prior to discharge from the outpatient surgery center. Following emergence from anesthesia, pain will be assessed in regular intervals, with administration of IV and oral opioids according to numeric rating scale and clinical assessment. Opioid administration stops when patient numerical rating score is <4, when patient endorses manageable pain level, when side effects of opioids are intolerable, or for other concerning clinical conditions as determined by the anesthesiologist of record.
Time Frame
Within 48 hours of emergence from anesthesia
Title
Nausea and Vomiting
Description
This is a yes/no binary outcome measure defined by administration of any antiemetic drug in the post-anesthesia care unit.
Time Frame
Beginning with emergence from anesthesia and ending with discharge from the post-anesthesia care unit (0-48 hours postoperativly)
Title
NLR -12 hours
Description
neutrophil/limphocyte ratio
Time Frame
12 hours postoperatively
Title
PLR -12 hours
Description
platelet/limphocyte ratio
Time Frame
12 hours postoperatively
Title
NLR - 24 hours
Description
neutrophil/limphocyte ratio
Time Frame
12 hours postoperatively
Title
PLR - 24 hours
Description
platelet/limphocyte ratio
Time Frame
12 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients < 18 years old undergoing scoliosis surgery Exclusion Criteria: refusal to participate > 18 yo Chronic opioid use localized infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Małgorzata Domagalska, PhD
Phone
608762068
Email
m.domagalska@icloud.com
First Name & Middle Initial & Last Name or Official Title & Degree
Małgorzata Domagalska
Email
m.domagalska@icloud.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Małgorzata Domagalska, PhD
Organizational Affiliation
Department of Palliative Medicine, University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tomasz Kotwicki, Profesor
Organizational Affiliation
Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
City
Poznań
State/Province
Wielkopolska
ZIP/Postal Code
61-545
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomasz Kotwicki, Profesor
Phone
+48618310157
Email
kckod@ump.edu.pl

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data presented in this study are available on request from the corresponding author.
IPD Sharing Time Frame
Data will become available after completing the study- December 2024
IPD Sharing Access Criteria
The data presented in this study are available on request from the corresponding author.

Learn more about this trial

Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery

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