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The purpose of this clinical trial is to evaluate whether bilateral lumbar erector spinae plane (ESP) block can reduce postoperative pain in adult patients undergoing lumbar spine surgery. The study also assesses the safety of this method and its effects on the recovery process. The main questions it aims to answer are:
Do patients who receive the ESP block experience less postoperative pain? Do these patients require fewer opioid (morphine-derived) analgesics? Does the first analgesic requirement occur later? Do patients mobilize earlier (stand/walk sooner)? Does the ESP block affect hemodynamic stability during and after surgery? Researchers will compare the ESP block group with the standard analgesia group to determine whether these effects occur.
Participants:
Patients in this study will be asked to:
Be randomly assigned to one of two groups before lumbar spine surgery Receive either a bilateral ESP block or standard analgesic therapy
Undergo postoperative follow-up including:
measurement of pain scores, recording of analgesic consumption, assessment of time to first analgesic requirement, monitoring of mobilization time, valuation of possible side effects
This randomized controlled study was designed to evaluate the effect of bilateral lumbar erector spinae plane (ESP) block on postoperative analgesia in patients undergoing lumbar spine surgery. A total of 102 patients scheduled for lumbar spine surgery were enrolled in the study and randomly assigned into two groups. One group received a bilateral ESP block at the L2-L4 levels using 20 mL of 0.25% bupivacaine on each side, while the control group received standard postoperative analgesia.
Postoperative pain assessment, opioid consumption, time to first analgesic request, mobilization time, intraoperative hemodynamic parameters, and the occurrence of adverse events were prospectively recorded according to a predefined follow-up protocol. The study was conducted using a prospective, randomized design to assess the efficacy and safety of bilateral lumbar ESP block for postoperative pain management in lumbar spine surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESP BLOCK, | Active Comparator |
| |
| CONTROL GROUP | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESP block group | Procedure | BILATERAL TWO-LEVEL ESP BLOCK WAS APPLIED TO PATIENTS UNDERGOING LUMBAR SPINAL SURGERY. |
|
| Measure | Description | Time Frame |
|---|---|---|
| VAS values of patients in the first 24 hours postoperatively | Zero indicates no pain, and 10 indicates the worst possible pain | The first 24 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| merve kaynak | Kütahya City Hospital | Principal Investigator |
| Ali Kaynak | Kütahya City Hospital | Study Chair |
| bilal a bezen | Afyonkarahisar Health Sciences University Hospital | Study Chair |
| remziye sıvacı | Afyonkarahisar Health Sciences University Hospital | Study Director |
| elif d bakı | Afyonkarahisar Health Sciences University Hospital | Study Chair |
| serhat yıldızhan | Afyonkarahisar Health Sciences University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Afyonkarahisar Health Sciences University Hospital | Afyonkarahisar | Merkez | 03000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27501016 | Background | Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. | |
| 34171466 | Result | Goel VK, Chandramohan M, Murugan C, Shetty AP, Subramanian B, Kanna RM, Rajasekaran S. Clinical efficacy of ultrasound guided bilateral erector spinae block for single-level lumbar fusion surgery: a prospective, randomized, case-control study. Spine J. 2021 Nov;21(11):1873-1880. doi: 10.1016/j.spinee.2021.06.015. Epub 2021 Jun 23. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2021 | Jan 7, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 24, 2021 | Jan 7, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| 31343504 | Result | Tseng V, Xu JL. Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: Is There a Better Option? J Neurosurg Anesthesiol. 2021 Jan;33(1):92. doi: 10.1097/ANA.0000000000000631. No abstract available. |
| 36800574 | Result | Liu H, Zhu J, Wen J, Fu Q. Ultrasound-guided erector spinae plane block for postoperative short-term outcomes in lumbar spine surgery: A meta-analysis and systematic review. Medicine (Baltimore). 2023 Feb 17;102(7):e32981. doi: 10.1097/MD.0000000000032981. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |