Erector Spinae Plane Block Clinical Trial
Official title:
Evaluation of the Effect of Erector Spinae Plane Block on Analgesic Consumption in Patients Scheduled for Percutaneous Balloon Kyphoplasty; Prospective Observational Study
NCT number | NCT05970380 |
Other study ID # | Kyphoplasty |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 20, 2023 |
Est. completion date | June 30, 2024 |
Patients, older than 50 years, with vertebral fracture scheduled for percutaneous balloon kyphoplasty will be enrolled for the study. Some patients will be under local anesthesia with sedation and analgesia for the procedure. Some patients will be performed erector spinae plane block with the guidance of ultrasonography for the procedure. The investigators aim to evaluate the intraoperative and postoperative analgesic requirement of patients. Surgeon's and patients' satisfaction will be also evaluated.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 30, 2024 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility | Inclusion Criteria: - American Society of Anesthesiologists physical status I, II, III, IV - Pathologic vertebra fracture - Percutaneous balloon kyphoplasty for single vertebrae Exclusion Criteria: - Contraindications for plane blocks (bleeding disorder, infection on the injection side) - Hemodynamic instability - Pregnancy - Patient's refusal - Vertebra fracture due to trauma - Multiple vertebra fractures - Procedure under general anesthesia - Allergy to local anesthetics |
Country | Name | City | State |
---|---|---|---|
Turkey | Izmir Bozyaka Training and Research Hospital | Izmir |
Lead Sponsor | Collaborator |
---|---|
Bozyaka Training and Research Hospital |
Turkey,
Demir U, Taskin O. Retrospective Comparison of Anesthetic Methods for Percutaneous Balloon Kyphoplasty Surgery: General Anesthesia and Erector Spinae Plane Block. Medicina (Kaunas). 2023 Jan 27;59(2):240. doi: 10.3390/medicina59020240. — View Citation
Ge C, Wu X, Gao Z, Xu Z, Hao D, Dong L. Comparison of different anesthesia modalities during percutaneous kyphoplasty of osteoporotic vertebral compression fractures. Sci Rep. 2021 May 27;11(1):11102. doi: 10.1038/s41598-021-90621-9. — View Citation
Verduzco LA. Erector spinae plane block as primary anesthetic for kyphoplasty. J Clin Anesth. 2020 May;61:109670. doi: 10.1016/j.jclinane.2019.109670. Epub 2019 Nov 26. No abstract available. — View Citation
Wu AM, Lin ZK, Ni WF, Chi YL, Xu HZ, Wang XY, Huang QS. The existence of intravertebral cleft impact on outcomes of nonacute osteoporotic vertebral compression fractures patients treated by percutaneous kyphoplasty: a comparative study. J Spinal Disord Tech. 2014 May;27(3):E88-93. doi: 10.1097/BSD.0b013e31829142bf. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opioid consumption during surgery | Opioid consumption will be assessed with the need of opioid analgesics and propofol during the surgical procedure. | Within first hour of the surgical procedure | |
Primary | Opioid consumption after surgery | Opioid consumption will be assessed with the need of opioid analgesics after the surgery. | Up to 24 hours after the surgical procedure | |
Primary | Pain during surgical procedure | Pain during the surgical procedure will be assessed by using numeric rating scale (NRS). NRS is between 0 and 10, where 0 is no pain and 10 is the worst pain. When the NRS is 4 or over 4 additional opioid analgesic will be given to the patient intravenously. | Within the first hour of the surgical procedure | |
Primary | Pain after surgical procedure | Pain will be assessed with numeric rating scale (NRS). NRS is between 0 and 10, where 0 is no pain and 10 is the worst pain. When the NRS is 4 or over 4, additional opioid analgesic will be given to the patient intravenously. | Up to 24 hours after the surgical procedure | |
Secondary | Surgeon's satisfaction | The surgeon will assess the ease of the procedure and patient's comfort during the procedure with Likert's scale; 1: very dissatisfied, 2: dissatisfied, 3: neither dissatisfied or satisfied, 4: satisfied, 5: very satisfied | Within 24 hours of the surgical procedure | |
Secondary | Patient's satisfaction | Patient will assess the comfort during intraoperative and postoperative period with Likert's scale 1: very dissatisfied, 2: dissatisfied, 4: neither dissatisfied or satisfied, 4: satisfied, 5: very satisfied | Within 24 hours of the surgical procedure |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04110210 -
Effectiveness of Bilateral Ultrasound-Guided Erector Spinae Plane Block
|
Early Phase 1 | |
Completed |
NCT03652103 -
Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy
|
Phase 4 | |
Recruiting |
NCT06088836 -
Ultrasound- Guided Continuous Retro Laminar Block Versus Continuous Erector Spinae Plane Block in Multiple Rib Fractures
|
N/A | |
Recruiting |
NCT04403360 -
Erector Spinae Plane Block After Lumbar Spinal Stenosis Surgery
|
N/A | |
Completed |
NCT05625009 -
Bilateral Ultrasound-Guided Transversus Abdominis Plane (Tap) Block and Erector Spinal Plane (Esp) Block
|
N/A | |
Not yet recruiting |
NCT06127966 -
The Relationship Between NLR and PONV and ESPB
|
Phase 1 | |
Completed |
NCT06143020 -
Effect of ESPB on Postoperative Pain in Patients With Breast Cancer Implant Reconstruction
|
N/A | |
Recruiting |
NCT05158270 -
Erector Spinae Plane Block As Alternative Analgesic Modality in Laparoscopic Cholecystectomy
|
N/A | |
Not yet recruiting |
NCT04845711 -
Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block in Laparoscopic Cholecystectomy
|
N/A | |
Recruiting |
NCT06377605 -
The Efficacy of Thoracic Erector Spinae Plane Block For Perioperative Analgesia in Laparoscopic Bariatric Surgery for Super Obese Patients: Randomized Controlled Trial.
|
N/A | |
Recruiting |
NCT06233617 -
Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Spine Surgery
|
Phase 4 | |
Not yet recruiting |
NCT04757480 -
Thoracolumbar Interfascial Plane Block Versus Bilateral Erector Spinae Plane Block In Lumbar Laminectomy
|
N/A | |
Active, not recruiting |
NCT04474873 -
Effectivenes of Erector Spinae Plane Block in Percutaneous Nephrolithotomy?
|
N/A | |
Recruiting |
NCT03887260 -
Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Nephrectomy/Nephron Sparing Surgery(NSS) Performed Via Lumbotomy
|
N/A | |
Completed |
NCT05083832 -
Effect of Two Different Plane Blocks on Post-thoracotomy Pain
|
N/A | |
Completed |
NCT05121727 -
Comparison of Erector Spinae Plane Block and Combination of Deep and Superficial Serratus Anterior Plane Block
|
N/A | |
Not yet recruiting |
NCT05409144 -
Impact of Thoracic Epidural Versus Serratus Anterior Plane Block Versus Erector Spinae Plane Block on Incidence of PTPS
|
N/A | |
Completed |
NCT03968146 -
Erector Spinae Plane Block in Scoliotic Adolescents
|
Phase 2 | |
Not yet recruiting |
NCT06441071 -
Patients' Positions on Analgesic Efficacy of ESPB
|
N/A | |
Recruiting |
NCT04420104 -
Errector Spinae Plane Block for Postoperative Pain Management in Cardiac Surgery: A Randomized Controlled Trial
|
N/A |