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N/A
Erector spinae plane block for Hysterectomy
N/A
Waitlist Available
Led By Cheng Lin
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult surgical patients who are American Society of Anesthesiologists (ASA) class I to III, undergoing cystectomy, or total abdominal hysterectomy, salpingo-oophrectomy with or without omentectomy via midline laparotomy.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12th to 24th postoperative hour
Awards & highlights
Study Summary
Regional anesthesia, also know as a nerve block, is a key component of pain control after major abdominal surgery. Bilateral erector spinae plane block (ESPB) performed at low thoracic level has been shown to be an effective pain control method in case reports. This pilot study aims to further characterize the pain-control characteristics and to provide baseline data for future trials.
Eligible Conditions
- Hysterectomy
- Cystectomy
- Regional Anesthesia
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12th to 24th postoperative hour
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12th to 24th postoperative hour
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Opioid consumption
Pain
Secondary outcome measures
Length of stay in hospital
Length of stay in post-anesthetic recovery unit
Number of participants with block related complication
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Erector spinae plane blockExperimental Treatment1 Intervention
The ESPB will be performed with ultrasound guidance. After identifying a suitable location between 8th and 10th thoracic spine transverse process, the overlying skin will be infiltrated with local anesthetic. A 22 gauge 90-mm needle will be inserted to make contact with the transverse process and withdraw slightly. Ropivacaine 0.5% 20 mL will be injected at this location. The same procedure will be performed on the other side.
Additionally, patients will receive acetaminophen, gabapentin and intravenous patient-controlled analgesia opioids.
Group II: Shame blockPlacebo Group1 Intervention
A sham block will be performed by performing ultrasound examination of the back looking for intended location for ESPB placement. Skin will be infiltrated with local anesthetics but ESPB will not be performed.
Additionally, patients will receive acetaminophen, gabapentin and intravenous patient-controlled analgesia opioids.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erector spinae plane block
2020
Completed Phase 4
~1300
Find a Location
Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
659 Previous Clinical Trials
413,720 Total Patients Enrolled
Cheng LinPrincipal InvestigatorWestern University
Frequently Asked Questions
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