- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07712224
Comparison of Epidural and Intravenous Analgesia in Laparoscopic Sleeve Gastrectomy Patients (EAvs IV in LSG)
Comparison of the Effects of Epidural and Intravenous Analgesia on Postoperative Lung Functions in Patients Undergoing Laparoscopic Sleeve Gastrectomy Surgery
Study Overview
Status
Intervention / Treatment
Detailed Description
This retrospective observational study was conducted at Trabzon Kanuni Training and Research Hospital. Adult patients who underwent laparoscopic sleeve gastrectomy between January 2025 and October 2025 were included. Patients were divided into two groups according to postoperative analgesia technique: epidural analgesia and intravenous analgesia.
The primary outcome was postoperative change in FEV1 at 24 hours after surgery. Secondary outcomes included changes in FVC and FEV1/FVC ratio, postoperative pain scores, additional opioid consumption, and intraoperative ventilatory parameters including peak airway pressure and plateau pressure.
Demographic data, perioperative variables, pulmonary function test results, arterial blood gas analyses, and analgesia-related data were retrospectively collected from hospital records. The study was approved by the Non-Interventional Scientific Research Ethics Committee of Trabzon University Faculty of Medicine.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Trabzon, Turkey (Türkiye)
- Trabzon Kanuni Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients aged 18-65 years
- ASA physical status III
- Undergoing laparoscopic sleeve gastrectomy
- Availability of preoperative and postoperative pulmonary function tests
- Availability of arterial blood gas analysis data
- Receipt of epidural or intravenous postoperative analgesia
Exclusion Criteria:
- Missing pulmonary function test data
- Incomplete medical records
- Conversion to open surgery
- Severe respiratory disease affecting pulmonary function assessment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Epidural Analgesia
Patients who received thoracic epidural analgesia for postoperative pain management after laparoscopic sleeve gastrectomy.
|
Thoracic epidural catheter-based analgesia using bupivacaine and fentanyl for postoperative pain management.
|
|
Intravenous Analgesia
Patients who received intravenous analgesia for postoperative pain management after laparoscopic sleeve gastrectomy.
|
Intravenous tramadol-based patient-controlled analgesia for postoperative pain management.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in FEV1 at 24 Hours After Surgery
Time Frame: Preoperative period and postoperative 24 hours
|
Assessment of postoperative change in forced expiratory volume in 1 second (FEV1) measured before surgery and at postoperative 24 hours.
|
Preoperative period and postoperative 24 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: esra kongur, M.D, Trabzon Kanuni Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TrabzonKERH-LSG-2025-01
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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