ESP Block for Pain Management

Overseen By Rongyu ( Cindy) Jin

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Recreational drugs

Disqualifiers: Bleeding disorders, Allergy to anesthetics, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ki Jinn Chin, MBBS, MMed,FRCPC

Principal Investigator

UHN

Eligibility Criteria

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.

Inclusion Criteria

I am in good health with no medical issues.

English speaking

My weight is between 60 and 100 kg.

Exclusion Criteria

Any recreational drug use

I feel unusual sensations in my chest, abdomen, or back.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive unilateral ESP block with different local anesthetic volumes across two visits

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for the duration and regression of sensory blockade post-ESP block

2-10 hours per visit

Treatment Details

Interventions

• 1.5% Lidocaine
• Erector Spinae Plane Block

Trial Overview 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.

Participant Groups

Group I: Group 30/20 Experimental Treatment 1 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 20/30 Experimental Treatment 1 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

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+