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Completed

NCT Number: NCT05012332

Local Anesthesia Spread After an Erector Spinae Plane Block.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ostfold Hospital Trust, Kalnes

Sarpsborg, Østfold fylke, 1714, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Erector Spinae Plane Block

Procedure

All volunteers receive an Erector Spinae Plane Block and an MRI.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Registry information

Official study title

A Magnetic Resonance Study to Evaluate the Spread of Local Anesthesia in Healthy Volunteers Receiving an Ultrasound-guided Erector Spinae Plane Block.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 19, 2021
Registry last updated
Sep 21, 2022

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.

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