- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07652177
Comparison of the Analgesic Efficacy of Erector Spinae Plane Block in Lumbar Microdiscectomy Surgeries
Comparison of the Analgesic Efficacy of Lumbar Erector Spinae Plane Block and Sacral Erector Spinae Plane Block in Lumbar Microdiscectomy Surgeries
Study Overview
Status
Detailed Description
Postoperative pain is commonly observed in patients undergoing lumbar microdiscectomy surgery.
To manage this pain, the lumbar erector spinae plane (ESP) block is frequently administered as part of a multimodal analgesia regimen, particularly with the aim of reducing opioid consumption in these patients.
Recent publications have demonstrated the analgesic efficacy of the sacral erector spinae plane block in lumbar microdiscectomy surgeries.
In this study, the postoperative analgesic effectiveness of the lumbar ESP block-performed two vertebral levels above the surgical site-will be compared with that of the sacral ESP block-performed two vertebral levels below the surgical site.
It is anticipated that this approach will provide effective analgesia while avoiding the use of opioids.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey (Türkiye)
- Gaziosmanpasa Research and Training Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
ASA I, ASA II, and ASA III patients scheduled for single-level lumbar microdiscectomy at the L4-L5 or L5-S1 level.
Exclusion Criteria:
Pregnant patients
Patients who do not consent to the erector spinae plane block
Patients requiring mechanical ventilatory support
Patients with a history of substance abuse
Patients with a known allergy to the medications to be used
Patients with bleeding diathesis
Patients with infection at the planned block site
Patients undergoing surgical intervention at two or more spinal levels
Patients with communication difficulties or intellectual disabilities
Patients with neuropsychiatric disorders
Patients with chronic pain
Patients with an expected surgical duration of 180 minutes or more
Patients with a prior history of lumbar microdiscectomy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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lumbar ESP
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sacral ESP
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
total tramadol consumption
Time Frame: first 24 hours after the surgery
|
first 24 hours after the surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
patients' visual analog scale
Time Frame: first 24 hours after the surgery
|
To compare postoperative Visual Analog Scale (VAS) pain scores at 2, 4, 8, 12, and 24 hours.
|
first 24 hours after the surgery
|
|
To compare analgesic consumption during the postoperative time intervals of 0-2, 2-4, 4-8, 8-12, and 12-24 hours.
Time Frame: first 24 hours after the surgery
|
postoperative 0-2, 2-4, 4-8, 8-12, and 12-24 hours.
|
first 24 hours after the surgery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GaziosmanpasaEAH LomberESP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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