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NCT Number: NCT07102108

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

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.

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Key information

Conditions

Lower Abdominal Surgery

Age range

18 day–80 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Trakya University, Faculty of Medicine

Edirne, Central, 22100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Tissue Oxygenation Levels Measured by NIRS

    Time frame: 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 outcomes

  1. Intraoperative Vital Signs

    Time frame: Intraoperative period

    Systolic blood pressure recorded during anesthesia

  2. Intraoperative Vital Signs

    Time frame: Intraoperative period

    Diastolic blood pressure recorded during anesthesia

  3. Intraoperative Vital Signs

    Time frame: Intraoperative period

    Heart rate recorded during anesthesia

  4. Intraoperative Vital Signs

    Time frame: Intraoperative period

    Oxygenation saturation recorded during anesthesia

  5. Visual Analog Scale(VAS) Pain Scores

    Time frame: 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.

  6. Qor-40 Questionnaire Scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

A Prospective Observational Study on the Effects of Anesthesia Techniques on Tissue Oxygenation and Postoperative Recovery in Lower Abdominal Surgery

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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