Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:32 PM
Study NCT ID:
NCT07431905
Status:
COMPLETED
Last Update Posted:
2026-02-25
First Post:
2026-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Erector Spinae Plane Block on Postoperative Analgesia and Stress Response in Laparoscopic Sleeve Gastrectomy
Sponsor:
Harran University
Organization:
Study Overview
Official Title:
Impact of Erector Spinae Plane Block on Postoperative Analgesia and Perioperative Stress Response in Sleeve Gastrectomy: A Prospective Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Effective postoperative analgesia is an important component of enhanced recovery after bariatric surgery. The erector spinae plane block (ESPB) is a regional anesthesia technique that has been increasingly used in abdominal and thoracic surgeries; however, its effects on postoperative analgesic requirements, pain scores, patient and surgeon satisfaction, hemodynamic parameters, and perioperative stress response in obese patients undergoing sleeve gastrectomy require further evaluation.
This study is designed as a prospective, randomized, single-blind clinical trial. After obtaining ethics committee approval (Şanlıurfa Harran University Hospital, date: 23.01.2023; decision no: HRÜ/23.02.09) and written/verbal informed consent, 60 patients aged 18-65 years, with a body mass index (BMI) \>30 and classified as ASA II-III, scheduled for elective sleeve gastrectomy will be included. Patients will be randomized into two groups: a group receiving bilateral ESPB (Group E, n=30) and a control group without ESPB (Group C, n=30).
Demographic characteristics, ASA classification, comorbidities, and duration of surgery will be recorded. Preoperative venous blood samples will be collected for hemogram (white blood cell count, lymphocyte count, neutrophil count) and biochemical analyses (C-reactive protein, cortisol, and glucose). Standard intraoperative monitoring (electrocardiography, peripheral oxygen saturation, and noninvasive blood pressure) will be applied, and heart rate (HR) and mean arterial pressure (MAP) will be recorded intraoperatively.
Postoperatively, HR and MAP, Numerical Rating Scale (NRS) pain scores at 0, 2, 4, 8, and 24 hours, opioid consumption, patient and surgeon satisfaction scores (Likert scale), postoperative hemogram and biochemical parameters, and any side effects or complications will be documented. All patients will receive dexketoprofen as baseline analgesia, and tramadol hydrochloride will be administered as rescue analgesic when required.
The primary objective of the study is to compare postoperative pain scores and analgesic requirements between patients receiving bilateral ESPB and those not receiving ESPB. Secondary objectives include the assessment of hemodynamic parameters, patient and surgeon satisfaction, and perioperative hematologic, biochemical, and stress-related parameters.
This study is designed as a prospective, randomized, single-blind clinical trial. After obtaining ethics committee approval (Şanlıurfa Harran University Hospital, date: 23.01.2023; decision no: HRÜ/23.02.09) and written/verbal informed consent, 60 patients aged 18-65 years, with a body mass index (BMI) \>30 and classified as ASA II-III, scheduled for elective sleeve gastrectomy will be included. Patients will be randomized into two groups: a group receiving bilateral ESPB (Group E, n=30) and a control group without ESPB (Group C, n=30).
Demographic characteristics, ASA classification, comorbidities, and duration of surgery will be recorded. Preoperative venous blood samples will be collected for hemogram (white blood cell count, lymphocyte count, neutrophil count) and biochemical analyses (C-reactive protein, cortisol, and glucose). Standard intraoperative monitoring (electrocardiography, peripheral oxygen saturation, and noninvasive blood pressure) will be applied, and heart rate (HR) and mean arterial pressure (MAP) will be recorded intraoperatively.
Postoperatively, HR and MAP, Numerical Rating Scale (NRS) pain scores at 0, 2, 4, 8, and 24 hours, opioid consumption, patient and surgeon satisfaction scores (Likert scale), postoperative hemogram and biochemical parameters, and any side effects or complications will be documented. All patients will receive dexketoprofen as baseline analgesia, and tramadol hydrochloride will be administered as rescue analgesic when required.
The primary objective of the study is to compare postoperative pain scores and analgesic requirements between patients receiving bilateral ESPB and those not receiving ESPB. Secondary objectives include the assessment of hemodynamic parameters, patient and surgeon satisfaction, and perioperative hematologic, biochemical, and stress-related parameters.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: