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Local Anesthesia Spread After an Erector Spinae Plane Block.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05012332
Recruitment Status : Completed
First Posted : August 19, 2021
Last Update Posted : September 21, 2022
Sponsor:
Information provided by (Responsible Party):
Marie Sørenstua, Ostfold Hospital Trust

Study Description
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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.


Condition or disease Intervention/treatment Phase
Regional Anesthesia Morbidity Postoperative Pain Procedure: Erector Spinae Plane Block Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: We aim to enroll 10 healthy volunteers. All volunteers receive the same intervention.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Magnetic Resonance Study to Evaluate the Spread of Local Anesthesia in Healthy Volunteers Receiving an Ultrasound-guided Erector Spinae Plane Block.
Actual Study Start Date : September 17, 2021
Actual Primary Completion Date : January 24, 2022
Actual Study Completion Date : January 24, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arms and Interventions
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Arm Intervention/treatment
Erector Spinae Plane Block
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.
 Procedure: Erector Spinae Plane Block
All volunteers receive an Erector Spinae Plane Block and an MRI.


Outcome Measures
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Primary Outcome Measures :
  1. Local anesthesia spread [ Time Frame: 60-120 min ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05012332


Locations
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Norway
Ostfold Hospital Trust, Kalnes
Sarpsborg, Ostfold, Norway, 1714
Sponsors and Collaborators
Ostfold Hospital Trust
Investigators
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Principal Investigator: Marie Soerenstua, MD Sykehuset Ostfold HF
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Marie Sørenstua, Principal investigator, Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT05012332    
Other Study ID Numbers: 212606
First Posted: August 19, 2021    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be available upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: At publication date and for three months.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marie Sørenstua, Ostfold Hospital Trust:
Erector Spinae Plane Block
Magnetic resonance imaging
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations