- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07348523
Comparison of the Postoperative Analgesic Efficacy of Classical and Modified Erector Spinae Plane Blocks After Lumbar Spinal Surgery
Comparison of the Effectiveness of Classical and Modified Erector Spinae Plane Blocks in Postoperative Analgesia Management Following Lumbar Spinal Surgery: A Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Lumbar spinal stenosis may lead to variable signs and symptoms such as low back pain, radiating pain to the lower extremities, and reduced walking capacity. Lumbar disc surgery itself causes significant pain due to extensive dissection and muscle retraction during the procedure. A multimodal analgesic approach is preferred for postoperative pain management after lumbar spine surgery. The addition of regional anesthesia techniques reduces opioid-related side effects and is associated with earlier mobilization, shorter hospital stay, and improved patient satisfaction.
In patients undergoing lumbar disc surgery, the classical erector spinae plane block and the modified erector spinae plane block provide effective analgesia for postoperative pain control.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: HALE KEFELİ ÇELİK
- Phone Number: 5057242409
- Email: ck_hale@hotmail.com
Study Contact Backup
- Name: BETÜL ÇİFTÇİ KURT
- Phone Number: 5301785995
- Email: betulciftcikurt@gmail.com
Study Locations
-
-
-
Samsun, Turkey (Türkiye)
- Recruiting
- Samsun University
-
Contact:
- HALE KEFELİ ÇELİK
- Email: ck_hale@hotmail.com
-
Contact:
- Betül ÇİFTÇİ KURT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 18-70 years,
- Classified as ASA physical status I-III,
- Scheduled to undergo single-level lumbar spinal surgery under general anesthesia
- Who agree to participate in the study by providing written informed consent
Exclusion Criteria:
- History of bleeding diathesis or current anticoagulant therapy
- Known allergy or hypersensitivity to local anesthetics or opioid medications
- Infection at the planned block injection site
- Previous lumbar spine surgery
- History of gabapentinoid or corticosteroid use within the last 3 weeks
- Inability to use a patient-controlled analgesia (PCA) device
- Suspected pregnancy, confirmed pregnancy, or breastfeeding Refusal to undergo the procedure or to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Active Comparator: Group K-ESP
The erector spinae plane block will be performed 30 minutes before lumbar spine surgery.
|
The erector spinae plane block will be performed under ultrasound guidance before the induction of general anesthesia.
|
|
Active Comparator: Active Comparator: Group M-ESP
The modified erector spinae plane block will be performed 30 minutes before lumbar spine surgery.
|
Modified erector spinae plane blocks will be performed under ultrasound guidance before the induction of general anesthesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid consumption
Time Frame: 24 hours
|
In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected and compared between groups.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of recovery 15 scale
Time Frame: 24 hours after surgery
|
Postoperative Quality of Recovery 15 in Turkish scale
|
24 hours after surgery
|
|
Perioperative pain intensity
Time Frame: 24 hours
|
Changes in the Numerical Rating Scale (NRS) will be recorded at rest and during movement. The participant's baseline NRS will be recorded, followed by measurements before and after neuraxial positioning and up to 24 hours post-surgery. The NRS is a unidimensional measure of pain intensity in adults. It is a segmented numerical version of the Visual Analog Scale (VAS) where the participant selects a whole number (0-10) that best represents the intensity of their pain. The 11-point numerical scale ranges from '0' representing one end of the pain spectrum (e.g. 'no pain') to '10' representing the other end (e.g. 'worst imaginable pain'). |
24 hours
|
|
Postoperative nausea and vomiting
Time Frame: 24 hours
|
Postoperative nausea and vomiting (PONV): During follow-up, patients who experience nausea or vomiting will be evaluated using a verbal descriptive PONV scale (0=None, 1=Mild nausea, 2=Moderate nausea, 3=Single episode of vomiting, 4=More than one episode of vomiting). |
24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMUKAEK 2025/247
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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