Local Anesthesia Spread After an Erector Spinae Plane Block.

NCT05012332 | Completed

• 1 other identifier: 212606
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia Morbidity; Postoperative Pain

Keywords

Erector Spinae Plane Block; Magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• 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.

  60-120 min

Study Arms (1)

Erector Spinae Plane Block

OTHER

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

Interventions

Erector Spinae Plane Block PROCEDURE

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

Erector Spinae Plane Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• No comorbidity

You may not qualify if:

• 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
• Metal implants not MRI-compatible

Sponsors & Collaborators

• Ostfold Hospital Trust: lead

Study Sites (1)

Ostfold Hospital Trust, Kalnes

Sarpsborg, Østfold fylke, 1714, Norway

Location

Related Publications (1)

• 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.

  PMID: 36351741 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Marie Soerenstua, MD

  Sykehuset Ostfold HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: We aim to enroll 10 healthy volunteers. All volunteers receive the same intervention.

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 19, 2021
• Study Start: September 17, 2021
• Primary Completion: January 24, 2022
• Study Completion: January 24, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: At publication date and for three months.

Locations

NO (1)