Erector Spinae Plane (ESP) Block Volunteer Study

NCT04401007 | Active Not Recruiting DMC

• 1 other identifier: 19-5863.0
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Although erector spinae plane (ESP) block reportedly provides postoperative pain relieve, controversy remains regarding the accuracy and consistency of analgesic success following ESP block. The goal of this study is to determine the extent and duration of clinical neural blockade following an ESP injection with different local anesthetic doses. Methods Twenty four healthy volunteers will be recruited, and each subject will make 2 separate visits to the study centre to undergo intervention and assessment. The 2 study visits will be separated by an interval of at least 2 weeks to ensure complete washout of any residual effects and a return to baseline status. At each study visit, the subject will receive a unilateral ESP block with 1.5% lidocaine and 5 mcg/mL epinephrine. Two different local anesthetic volumes will be investigated: 20 mL (300 mg lidocaine) at one study visit and 30 mL (450 mg lidocaine) at the other study visit. Volunteers will be randomized to one of two intervention groups: (1) Group 20/30: A unilateral ESP block with 20 mL of local anesthetic at the first visit, and 30 mL of local anesthetic at the second visit; or (2) Group 30/20: a unilateral ESP block with 30 mL of 1.5% lidocaine with 1/200,000 epinephrine at the first visit, and 20 mL of the same local anesthetic solution at the second visit. There will be 2 study subgroups based on the vertebral level at which the ESP block is administered: (1) Volunteer subjects in subgroup TP4 will receive the ESP block injection at the T4 transverse process (TP4) level in order to evaluate the anesthetic effect on the chest wall. (2) Volunteers in subgroup TP8 will receive the ESP block injection at the T8 transverse process (TP8) level in order to evaluate the anesthetic effect on the abdominal wall. The first 10 volunteer subjects recruited will receive ESP blocks at the TP4 level and the subsequent 10 subjects will receive ESP blocks at the TP8 level.

Conditions

Pain Management

Outcome Measures

Primary Outcomes (4)

• the duration of sensory blockade Sensation to Pinprick of thoracic ventral rami

  duration of ESP block Sensation to Pinprick

  up to 10 hours

• the duration of sensory blockade Sensation to Pinprick of thoracic dorsal rami

  duration of ESP block Sensation to Pinprick

  up to 10 hours

• the duration of sensory blockade Sensation to temperature of thoracic ventral rami

  duration of ESP block Sensation to different temperature

  up to 10 hours

• the duration of sensory blockade Sensation to temperature of thoracic dorsal rami

  duration of ESP block Sensation to different temperature

  up to 10 hours

Secondary Outcomes (7)

• To evaluate the onset of pinprick blockade of an ESP block injection

  up to 2 hours

• To evaluate the onset of temperature blockade of an ESP block

  up to 2 hours

• To evaluate the regression of pinprick blockade of an ESP block injection

  post-block 2-10 hours

• To evaluate the regression of temperature blockade of an ESP block injection

  post-block 2-10 hours

• To evaluate the success of blockade on Skin Conductance of an ESP block injection

  0-2 hours

Study Arms (2)

Group 20/30

EXPERIMENTAL

Two different local anesthetic volumes will be investigated: 20 mL of 1.5% lidocaine (300 mg lidocaine) at one study visit and 30 mL of 1.5% lidocaine (450 mg lidocaine) at the other study visit. Volunteers will be randomized to one of two intervention groups: (1) Group 20/30: A unilateral ESP block with 20 mL of local anesthetic at the first visit, and 30 mL of local anesthetic at the second visit

Other: Erector Spinae Plane Block with 1.5% lidocaine

Group 30/20

EXPERIMENTAL

(2) Group 30/20: a unilateral ESP block with 30 mL of 1.5% lidocaine with 1/200,000 epinephrine at the first visit, and 20 mL of the same local anesthetic solution at the second visit. This crossover design allows subjects to serve as their own control.

Other: Erector Spinae Plane Block with 1.5% lidocaine

Interventions

Erector Spinae Plane Block with 1.5% lidocaine OTHER

Erector spinae plane (ESP) block is a new regional nerve block technique that involves a percutaneous injection of local anesthetic as a bolus through a needle or catheter into the fascial plane between the erector spinae muscle and the transverse processes in the upper or mid back.

Group 20/30; Group 30/20

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA 1 (normal healthy) volunteers
• years of age
• kg weight
• English speaking
• female volunteers of childbearing potential will be required to provide a negative pregnancy test before being allowed to participate, females of child bearing potential must be willing to use medically acceptable birth control methods for a minimum of 2 weeks following the nerve block.

You may not qualify if:

• weight \< 60 kg (limited by the maximum lidocaine dose 7 mg/kg)
• medical disorders (including bleeding disorders)
• any recreational drug use
• allergy to local anesthetic (lidocaine, bupivacaine, ropivacaine)
• contraindication to regional anesthetic block
• inability to provide informed consent
• baseline abnormality of chest, abdominal and back sensation
• pregnancy / breast feeding
• individuals with mental health disorders (for example bipolar disorder or depression).

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ki Jinn Chin, MBBS, MMed,FRCPC

  UHN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Two different local anesthetic volumes will be investigated: 20 mL (300 mg lidocaine) at one study visit and 30 mL (450 mg lidocaine) at the other study visit. Volunteers will be randomized to one of two intervention groups: (1) Group 20/30: A unilateral ESP block with 20 mL of local anesthetic at the first visit, and 30 mL of local anesthetic at the second visit; or (2) Group 30/20: a unilateral ESP block with 30 mL of 1.5% lidocaine with 1/200,000 epinephrine at the first visit, and 20 mL of the same local anesthetic solution at the second visit. Randomization of subjects to either Group 20/30 or Group 30/20 will be done using computer software and only the study investigator performing the ESP block will be aware of the study allocation. Volunteer subjects and the study investigators responsible for serial neurologic and other outcome assessments after injection will be blinded to the volume of local anesthetic injected.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be 2 study subgroups based on the vertebral level at which the ESP block is administered: (1) Volunteer subjects in subgroup TP4 will receive the ESP block injection at the T4 transverse process (TP4) level. Injection at the TP4 level will allow us to evaluate the anesthetic effect on the chest wall. (2) Volunteers in subgroup TP8 will receive the ESP block injection at the T8 transverse process (TP8) level. Injection at the TP8 level will allow us to evaluate the anesthetic effect on the abdominal wall. The first 12 volunteer subjects recruited will receive ESP blocks at the TP4 level and the subsequent 12 subjects will receive ESP blocks at the TP8 level.

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 26, 2020
• Study Start: July 28, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)