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Local Anesthetic

ESP Block for Pain Management

N/A

Waitlist Available

Led By Vincent Chan, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ASA 1 (normal healthy) volunteers

18 - 50 years of age

Must not have

Contraindication to regional anesthetic block

Inability to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-block 2-10hours

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate whether different doses of local anesthetic for ESP blocks result in different degrees or duration of clinical neural blockade.

Who is the study for?

Healthy volunteers aged 18-50, weighing between 65-100 kg, and fluent in English can participate. Women able to have children must test negative for pregnancy and agree to use birth control during the study.

What is being tested?

The trial is testing how well an ESP block with lidocaine manages pain after surgery. Volunteers will receive two different doses of the anesthetic at separate visits to see which works better for chest or abdominal wall pain relief.

What are the potential side effects?

Possible side effects from the ESP block may include temporary numbness, weakness in the injected area, light-headedness, or a rare risk of infection at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am in good health with no medical issues.

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I am between 18 and 50 years old.

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My weight is between 60 and 100 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have certain types of numbing medication due to health reasons.

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I am unable to understand or sign the consent form.

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I weigh less than 60 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-block 2-10hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-block 2-10hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-block 2-10hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

+1 more

Secondary study objectives

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

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

To evaluate the onset of temperature blockade of an ESP block

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 30/20Experimental Treatment1 Intervention

(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.

Group II: Group 20/30Experimental Treatment1 Intervention

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

0 / 6Eligibility criteria met