Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
102 participants
INTERVENTIONAL
2021-09-27
2022-05-20
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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ESP BLOCK,
ESP block group
BILATERAL TWO-LEVEL ESP BLOCK WAS APPLIED TO PATIENTS UNDERGOING LUMBAR SPINAL SURGERY.
CONTROL GROUP
No interventions assigned to this group
Interventions
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ESP block group
BILATERAL TWO-LEVEL ESP BLOCK WAS APPLIED TO PATIENTS UNDERGOING LUMBAR SPINAL SURGERY.
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists Patient Classification Score (ASA) between I and Ⅲ
* Patients who can cooperate and give consent
* No chronic analgesic or opioid use
* No mental or psychiatric disorders
* No alcohol or illicit drug use
* Patients scheduled for elective spinal surgery
Exclusion Criteria
* Foreign nationals who could not be contacted
* Patients under 18 and over 80
* Patients with an ASA score of Ⅳ or higher
* Patients scheduled for emergency surgery
* Pregnant women and breastfeeding mothers
* Bleeding diathesis
* Drug allergy
* Anticoagulant use
* Local/systemic infection
* Serious arrhythmia
18 Years
80 Years
ALL
Yes
Sponsors
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Kutahya City Hospital
OTHER
Responsible Party
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MERVE KAYNAK
specialist doctor
Principal Investigators
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merve kaynak
Role: PRINCIPAL_INVESTIGATOR
Kütahya City Hospital
Ali Kaynak
Role: STUDY_CHAIR
Kütahya City Hospital
bilal a bezen
Role: STUDY_CHAIR
Afyonkarahisar Health Sciences University Hospital
remziye sıvacı
Role: STUDY_DIRECTOR
Afyonkarahisar Health Sciences University Hospital
elif d bakı
Role: STUDY_CHAIR
Afyonkarahisar Health Sciences University Hospital
serhat yıldızhan
Role: STUDY_CHAIR
Afyonkarahisar Health Sciences University Hospital
Locations
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Afyonkarahisar Health Sciences University Hospital
Afyonkarahisar, Merkez, Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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448
Identifier Type: -
Identifier Source: org_study_id
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