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

This retrospective observational study aimed to compare the effects of epidural analgesia and intravenous analgesia on early postoperative pulmonary function in patients undergoing laparoscopic sleeve gastrectomy. Preoperative and postoperative pulmonary function tests, pain scores, opioid consumption, and intraoperative respiratory parameters were evaluated.

Study Overview

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

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Trabzon, Turkey (Türkiye)
        • Trabzon Kanuni Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult obese patients undergoing laparoscopic sleeve gastrectomy at a tertiary training and research hospital.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: esra kongur, M.D, Trabzon Kanuni Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

October 15, 2025

Study Completion (Actual)

October 15, 2025

Study Registration Dates

First Submitted

July 14, 2026

First Submitted That Met QC Criteria

July 14, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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