NCT07712224

Brief 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. Preoperative and postoperative pulmonary function tests, pain scores, opioid consumption, and intraoperative respiratory parameters were evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
Last Updated

July 17, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

July 14, 2026

Last Update Submit

July 14, 2026

Conditions

Keywords

Epidural AnalgesiaIntravenous AnalgesiaPulmonary FunctionFEV1Postoperative AnalgesiaObesityBariatric Surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    Preoperative period and postoperative 24 hours

Study Arms (2)

Epidural Analgesia

Patients who received thoracic epidural analgesia for postoperative pain management after laparoscopic sleeve gastrectomy.

Procedure: Epidural analgesia (0.125% bupivacaine/2mcg fentanyl solution)

Intravenous Analgesia

Patients who received intravenous analgesia for postoperative pain management after laparoscopic sleeve gastrectomy.

Drug: Intravenous analgesia

Interventions

Intravenous tramadol-based patient-controlled analgesia for postoperative pain management.

Intravenous Analgesia

Thoracic epidural catheter-based analgesia using bupivacaine and fentanyl for postoperative pain management.

Epidural Analgesia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Missing pulmonary function test data
  • Incomplete medical records
  • Conversion to open surgery
  • Severe respiratory disease affecting pulmonary function assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trabzon Kanuni Training and Research Hospital

Trabzon, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Officials

  • esra kongur, M.D

    Trabzon Kanuni Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 17, 2026

Study Start

January 1, 2025

Primary Completion

October 15, 2025

Study Completion

October 15, 2025

Last Updated

July 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations