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Erector Spinae Plane (ESP) Block Volunteer Study

NCT04401007 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-07-23

No results posted yet for this study

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

Interventions

OTHER

Erector Spinae Plane Block with 1.5% lidocaine

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.

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Ki Jinn Chin, MBBS, MMed,FRCPC · UHN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-28
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04401007 on ClinicalTrials.gov