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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Epidural and Intravenous Analgesia on Postoperative Lung Functions in Patients Undergoing Laparoscopic Sleeve Gastrectomy Surgery
- ClinicalTrials.gov ID
- NCT07712224
- Acronym / sponsor ID
- EAvs IV in LSG / TrabzonKERH-LSG-2025-01
- Conditions
- Obesity, Bariatric Surgery, Laparoscopic Sleeve Gastrectomy
- Keywords
- Epidural Analgesia, Intravenous Analgesia, Pulmonary Function, FEV1, Postoperative Analgesia, Obesity, Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Trabzon Kanuni Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural Analgesia | – | Procedure: Epidural analgesia (0.125% bupivacaine/2mcg fentanyl solution)Patients who received thoracic epidural analgesia for postoperative pain management after laparoscopic sleeve gastrectomy. |
| Intravenous Analgesia | – | Drug: Intravenous analgesiaPatients who received intravenous analgesia for postoperative pain management after laparoscopic sleeve gastrectomy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult obese patients undergoing laparoscopic sleeve gastrectomy at a tertiary training and research hospital.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Missing pulmonary function test data
- Incomplete medical records
- Conversion to open surgery
- Severe respiratory disease affecting pulmonary function assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural analgesia (0.125% bupivacaine/2mcg fentanyl solution)Thoracic epidural catheter-based analgesia using bupivacaine and fentanyl for postoperative pain management. | Procedure or surgery | Epidural Analgesia |
| Intravenous analgesiaIntravenous tramadol-based patient-controlled analgesia for postoperative pain management. | Drug | Intravenous Analgesia |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
esra kongur, M.D principal investigator
Trabzon Kanuni Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Bariatric Surgery, run by Trabzon Kanuni Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FEV1 at 24 Hours After Surgery (time frame: Preoperative period and postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.