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Local Anesthesia Spread After an Erector Spinae Plane Block.

Primary Purpose

Regional Anesthesia Morbidity, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Erector Spinae Plane Block
Sponsored by
Ostfold Hospital Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Regional Anesthesia Morbidity focused on measuring Erector Spinae Plane Block, Magnetic resonance imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age > 18 years
  • No comorbidity

Exclusion Criteria:

  • Allergy to latex, gadolinium and local anesthesia
  • BMI >40
  • Severe renal and/or hepatic disease
  • Local infection at the site of injection
  • Systemic infection
  • AV block 2-3
  • Inability to understand written or spoken Norwegian
  • Inability to cooperate
  • Claustrophobia
  • Pregnancy - All fertile women will be asked to perform a pregnancy test to ensure that they aren't pregnant before inclusion.
  • Metal implants not MRI-compatible

Sites / Locations

  • Ostfold Hospital Trust, Kalnes

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Erector Spinae Plane Block

Arm Description

All volunteers will be given the choice of procedural pain relief in the form of rapifen 0,5-1 mg. All volunteers included will receive an unilateral ESPB at the T7 level with 30 ml of 2,5 mg/ml ropivacaine and a total of 0,3 mmol gadolinium. The intervention will be performed by the PhD candidate connected to the study. The ESPB will be performed under ultrasound guidance, where the needle target is the transverse process of the Th7 vertebra, under the musculus (m.) erector spinae. All volunteers will be tested for cold and pinprick sensation 30 minutes after block completion, and the results plotted on a dermatome map before they undergo an MRI.

Outcomes

Primary Outcome Measures

Local anesthesia spread
A 3T MRI examination (Magnetom Skyra, Siemens) will be performed 60 minutes after the injection, covering spine levels Th3 to Th12. 3D T1-weighted sequences with fat suppression as well as a T2-weighted sequence will be performed. The distribution pattern of the ropivacaine-gadolinium solution will be evaluated in the following structures: superficial, paravertebral and intercostal musculature, neural foramina and epidural space.

Secondary Outcome Measures

Full Information

First Posted
August 12, 2021
Last Updated
September 20, 2022
Sponsor
Ostfold Hospital Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05012332
Brief Title
Local Anesthesia Spread After an Erector Spinae Plane Block.
Official Title
A Magnetic Resonance Study to Evaluate the Spread of Local Anesthesia in Healthy Volunteers Receiving an Ultrasound-guided Erector Spinae Plane Block.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
January 24, 2022 (Actual)
Study Completion Date
January 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ostfold Hospital Trust

4. Oversight

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

5. Study Description

Brief Summary
This a single-center prospective spread-evaluation study where the primary objective is to assess the spread of local anesthesia in an ESPB using magnetic resonance imaging (MRI). The investigators will include 10 healthy volunteers from the hospitals internal website. All volunteers will receive a one-sided Erector Spinae Plane (ESP) block. 30 min after the block sensitivity to cold and pinprick will be assessed before an MRI is performed after 60 min postblock. An radiology specialist will evaluate the MR images pertaining to the spread of the local anesthesia.
Detailed Description
Healthy volunteers working at Ostfold Hospital will be recruited by a message put up on the hospitals intranet front page. As participants makes contact, they will receive a mail sent by a study nurse. The mail will include the patient information sheet and a consent form. There will be offered compensation in the form of a gift card of 1000 NOK to cover any travel expenses. Any travel expenses exceeding 1000 NOK will not be covered. If the volunteer fulfills the eligibility criteria and consent is obtained, the study nurse will contact the volunteer per phone or mail to set up an intervention date. The investigators aim to enroll 10 healthy volunteers and perform the intervention within six months. The planned project end is during December 2022. All volunteers will be given the choice of procedural pain relief in the form of rapifen 0,5-1 mg. All volunteers included will receive an unilateral ESPB at the T7 level with 30 ml of 2,5 mg/ml ropivacaine and a total of 0,3 mmol gadolinium. The intervention will be performed by the PhD candidate connected to the study. The ESPB will be performed under ultrasound guidance, where the needle target is the transverse process of the Th7 vertebra, under the musculus (m.) erector spinae. All volunteers will be tested for cold and pinprick sensation 30 minutes after block completion, and the results plotted on a dermatome map before they undergo an MRI. Magnetic resonance imaging study A 3T MRI examination (Magnetom Skyra, Siemens) will be performed 60 minutes after the injection, covering spine levels Th3 to Th12. 3D T1-weighted sequences with fat suppression as well as a T2-weighted sequence will be performed. The distribution pattern of the ropivacaine-gadolinium solution will be evaluated in the following structures: superficial, paravertebral and intercostal musculature, neural foramina and epidural space. All images will be reviewed and analyzed by the same radiologist.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regional Anesthesia Morbidity, Postoperative Pain
Keywords
Erector Spinae Plane Block, Magnetic resonance imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
We aim to enroll 10 healthy volunteers. All volunteers receive the same intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erector Spinae Plane Block
Arm Type
Other
Arm Description
All volunteers will be given the choice of procedural pain relief in the form of rapifen 0,5-1 mg. All volunteers included will receive an unilateral ESPB at the T7 level with 30 ml of 2,5 mg/ml ropivacaine and a total of 0,3 mmol gadolinium. The intervention will be performed by the PhD candidate connected to the study. The ESPB will be performed under ultrasound guidance, where the needle target is the transverse process of the Th7 vertebra, under the musculus (m.) erector spinae. All volunteers will be tested for cold and pinprick sensation 30 minutes after block completion, and the results plotted on a dermatome map before they undergo an MRI.
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block
Intervention Description
All volunteers receive an Erector Spinae Plane Block and an MRI.
Primary Outcome Measure Information:
Title
Local anesthesia spread
Description
A 3T MRI examination (Magnetom Skyra, Siemens) will be performed 60 minutes after the injection, covering spine levels Th3 to Th12. 3D T1-weighted sequences with fat suppression as well as a T2-weighted sequence will be performed. The distribution pattern of the ropivacaine-gadolinium solution will be evaluated in the following structures: superficial, paravertebral and intercostal musculature, neural foramina and epidural space.
Time Frame
60-120 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age > 18 years No comorbidity Exclusion Criteria: Allergy to latex, gadolinium and local anesthesia BMI >40 Severe renal and/or hepatic disease Local infection at the site of injection Systemic infection AV block 2-3 Inability to understand written or spoken Norwegian Inability to cooperate Claustrophobia Pregnancy - All fertile women will be asked to perform a pregnancy test to ensure that they aren't pregnant before inclusion. Metal implants not MRI-compatible
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Soerenstua, MD
Organizational Affiliation
Sykehuset Ostfold HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ostfold Hospital Trust, Kalnes
City
Sarpsborg
State/Province
Ostfold
ZIP/Postal Code
1714
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be available upon request.
IPD Sharing Time Frame
At publication date and for three months.
Citations:
PubMed Identifier
36351741
Citation
Sorenstua M, Zantalis N, Raeder J, Vamnes JS, Leonardsen AL. Spread of local anesthetics after erector spinae plane block: an MRI study in healthy volunteers. Reg Anesth Pain Med. 2023 Feb;48(2):74-79. doi: 10.1136/rapm-2022-104012. Epub 2022 Nov 9.
Results Reference
derived

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Local Anesthesia Spread After an Erector Spinae Plane Block.

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