Effects of Anesthesia Techniques on Tissue Oxygenation and Recovery in Lower Abdominal Surgery

Completed

• Conditions: Lower Abdominal Surgery

• Registration Number: NCT07102108
• Lead Sponsor: Trakya University

Brief Summary

This is a prospective observational study designed to evaluate the effects of different anesthesia techniques on tissue oxygenation and postoperative recovery in patients undergoing lower abdominal surgery. A total of 180 patients will be enrolled and evenly allocated into four groups based on the anesthesia method used: general anesthesia, spinal anesthesia, epidural anesthesia, and combined general plus epidural anesthesia.

Near-infrared spectroscopy (NIRS) will be utilised to monitor tissue oxygenation at the thenar and plantar regions during the perioperative period. Vital signs, VAS scores(min 0-max 10 points), Quality of Recovery-40 (QoR-40) scores(min 40-max 200 points), and additional postoperative recovery parameters- including length of stay in the post-anesthesia care unit and hospital, surgical site infection, wound revision, and mortality- will be recorded and compared across the groups.

The primary hypothesis is that regional anesthesia techniques enchance tissue oxygenation and are associated with improved postoperative recovery outcomes compared to general anesthesia alone. The study was approved by the local ethics committee and will be conducted at a single tertiary-care center.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-03
• Study First Submitted QC: 2025-08-01
• Last Update Submitted: 2025-08-01
• Study First Posted: 2025-08-03
• Last Update Posted: 2025-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Adults aged 18-80 years
• Scheduled for elective lower abdominal surgery
• Eligible for general, spinal, epidural or combined anesthesia techniques
• Provided writen informed consent
• ASA physical status 1-3

Exclusion Criteria

• Refusal to participate
• Emergency surgery
• Severe cardiovascular or respiratory instability
• Pre-existing severe cognitive impairment of communication barrier
• Peripheral vascular disease affecting NIRS readind
• Local infection or anatomical anomaly preventing regional anesthesia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tissue Oxygenation Levels Measured by NIRS	From baseline(pre-op) to end of surgery	Continuous measurement of tissue oxygenation at thenar and plantar sites using near-infrared spectroscopy during perioperative period

Secondary Outcome Measures

Name	Time	Method
Intraoperative Vital Signs	Intraoperative period	Oxygenation saturation recorded during anesthesia
Visual Analog Scale(VAS) Pain Scores	Up to 24 hours after surgery	VAS pain scores measured postoperatively at PACU and postoperative day 1. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate worse outcomes.
Qor-40 Questionnaire Scores	postoperative day 1	Quality of Recovery scores assessed using the Qor-40 questionnaire on postoperative day1. The total score ranges from 40 to 200, with higher scores indicating better recovery.

Trial Locations

Locations (1)

Trakya University, Faculty of Medicine; 🇹🇷 Edirne, Central, Turkey