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ESP Block for Post-Surgery Pain
N/A
Recruiting
Led By Michael Dinsmore, 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
All adult patients aged 18-80 years with ASA class I - III undergoing posterior cervical (C3-T2) decompression and instrumented fusion for cervical stenosis in prone position.
Be older than 18 years old
Must not have
Extradural or intradural cervical tumors
Surgery of C1 and C2 spine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks and one month
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Summary
This trial shows that ESP block can reduce post-op pain & improve patient activity, reducing the risk of persistent pain & psychological distress.
Who is the study for?
Adults aged 18-80 with moderate health (ASA class I - III) who are having specific neck spine surgery for cervical stenosis can join. Not for those with certain spine conditions, very poor health (ASA IV), no consent, pregnancy, or allergy to local anesthetics.
What is being tested?
The trial is testing if a pain block called ESP with Lidocaine/Bupivacaine reduces opioid use and improves recovery after neck spine surgery compared to the same block using a placebo.
What are the potential side effects?
Possible side effects include reactions at the injection site, nerve damage risks, low blood pressure from anesthesia drugs like Lidocaine/Bupivacaine, and allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18-80 years old and need surgery for neck narrowing.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer is located in the cervical spine area.
Select...
I have had surgery on the upper part of my spine.
Select...
I have a broken neck.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks and one month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks and one month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Quality of Recovery 40 Questionnaire
Secondary study objectives
Opioids consumption
Pain
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Study groupExperimental Treatment1 Intervention
Bilateral ESP block at T1 level with 20 ml of 1:1 mixture (2% Lidocaine: 0.5% bupivacaine)
Group II: Placebo GroupPlacebo Group1 Intervention
Bilateral ESP block at T1 level with 20 ml of 0.9% normal saline
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,531 Previous Clinical Trials
504,270 Total Patients Enrolled
6 Trials studying Pain
1,620 Patients Enrolled for Pain
Michael Dinsmore, MDPrincipal InvestigatorUniversity Health Network, Toronto
2 Previous Clinical Trials
103 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is located in the cervical spine area.You are allergic to numbing medications used during procedures.I am between 18-80 years old and need surgery for neck narrowing.I have had surgery on the upper part of my spine.I have a broken neck.
Research Study Groups:
This trial has the following groups:- Group 1: Study group
- Group 2: Placebo Group
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.