ObesityEAvs IV in LSGNCT07712224
Comparison of Epidural and Intravenous Analgesia in Laparoscopic Sleeve Gastrectomy Patients
An observational study of Obesity and Bariatric Surgery, run by Trabzon Kanuni Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Bariatric Surgery, Laparoscopic Sleeve Gastrectomy
- What is being tested?
- Epidural analgesia (0.125% bupivacaine/2mcg fentanyl solution) and Intravenous analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 15 Oct 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult obese patients undergoing laparoscopic sleeve gastrectomy at a tertiary training and research hospital.
Who may be able to join
- 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
Who cannot join
- Missing pulmonary function test data
- Incomplete medical records
- Conversion to open surgery
- Severe respiratory disease affecting pulmonary function assessment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trabzon Kanuni Training and Research Hospital
Trabzon
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Bariatric Surgery, Laparoscopic Sleeve Gastrectomy
- Being tested
- Epidural analgesia (0.125% bupivacaine/2mcg fentanyl solution), Intravenous analgesia
- Keywords
- Epidural Analgesia, Intravenous Analgesia, Pulmonary Function, FEV1, Postoperative Analgesia, Obesity, Bariatric Surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural analgesia (0.125% bupivacaine/2mcg fentanyl solution)Procedure or surgery
Thoracic epidural catheter-based analgesia using bupivacaine and fentanyl for postoperative pain management.
Intravenous analgesiaDrug
Intravenous tramadol-based patient-controlled analgesia for postoperative pain management.
| Study group | Role | What they receive |
|---|---|---|
| Epidural Analgesia | Patients who received thoracic epidural analgesia for postoperative pain management after laparoscopic sleeve gastrectomy. Receives: Procedure: Epidural analgesia (0.125% bupivacaine/2mcg fentanyl solution) | |
| Intravenous Analgesia | Patients who received intravenous analgesia for postoperative pain management after laparoscopic sleeve gastrectomy. Receives: Drug: Intravenous analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FEV1 at 24 Hours After Surgery
Assessment of postoperative change in forced expiratory volume in 1 second (FEV1) measured before surgery and at postoperative 24 hours.
Measured: Preoperative period and postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Jan 2025
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trabzon Kanuni Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- esra kongur, M.D, Principal investigator, Trabzon Kanuni Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712224
- Sponsor's protocol ID
- TrabzonKERH-LSG-2025-01
- Acronym
- EAvs IV in LSG
- Status last verified
- Apr 2026
- First submitted
- 14 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No