- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07363096
Single- Versus Two-Level ESP Block for Analgesia After Lumbar Stabilization Surgery (ESP-Lumbar)
Comparison Of Single- Versus Two-Level Erector Spinae Plane Block For Postoperative Analgesia In Patients Undergoing Lumbar Stabilization Surgery
Lumbar stabilization surgery is commonly associated with moderate to severe postoperative pain. Effective pain control is important to improve patient comfort, early mobilization, and recovery. The erector spinae plane (ESP) block is a regional anesthesia technique that has been increasingly used for postoperative pain management in spine surgery.
This study aims to compare the effectiveness of single-level versus two-level ultrasound-guided ESP block for postoperative pain control in patients undergoing lumbar stabilization surgery. Patients will be randomly assigned to receive either a single-level ESP block or a two-level ESP block in addition to standard analgesic treatment.
Postoperative pain scores, opioid consumption, and the incidence of side effects will be evaluated during the postoperative period. The results of this study may help determine the most effective ESP block technique for pain management after lumbar stabilization surgery.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hatice Ayça SARIBUDAK, MD
- Phone Number: 905437290893
- Email: aycasaribudak@gmail.com
Study Locations
-
-
Yenimahalle
-
Ankara, Yenimahalle, Turkey (Türkiye), 06170
- Ankara Etlik City Hospital
-
Contact:
- Hatice Ayça SARIBUDAK, MD
- Phone Number: 905437290893
- Email: aycasaribudak@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ASA I-II-III,
- BMI:18-40,
- Patients undergoing lumbar stabilization surgery involving 2 to 4 vertebral levels
- Patients who personally provide written informed consent to participate in the study
Exclusion Criteria:
- Patients with chronic pain conditions
- Patients with a history of chronic opioid use
- Patients undergoing emergency lumbar stabilization surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Single Level Erector Spinae Plane Block
Participants in this arm will receive an ultrasound-guided erector spinae plane (ESP) block performed at a single vertebral level corresponding to the surgical site, in addition to standardized general anesthesia and postoperative multimodal analgesia.
|
Ultrasound-guided erector spinae plane block performed at a single vertebral level for postoperative analgesia.
|
|
Active Comparator: Two Level Erector Spinae Plane Block
Participants in this arm will receive an ultrasound-guided erector spinae plane (ESP) block performed at two adjacent vertebral levels, in addition to standardized general anesthesia and postoperative multimodal analgesia.
|
Ultrasound-guided erector spinae plane block performed at two adjacent vertebral levels for postoperative analgesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative Remifentanyl Consumption
Time Frame: During the intraoperative period
|
The amount of Remifentanyl that patients need to maintain anesthesia during the intraoperative period will be recorded
|
During the intraoperative period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Scores
Time Frame: First 24 hours after surgery
|
Pain will be assessed at rest and while movement using the from 0 ( no pain) to 10 (worst pain).
Pain assessment will be done at the 1st, 2nd, 4th, 12th and 24th hours after surgery
|
First 24 hours after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
- AEŞH-EK1-2023-250
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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