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OpenTrials
Completed

NCT Number: NCT07097220

Effects of Different Anesthetic Techniques on Intraoperative and Postoperative Pain Levels and Cognitive Function in Patients Undergoing Hepatectomy for Liver Cancer

To evaluate the effects of general anesthesia (GA) versus combined general and epidural anesthesia (GEA) on postoperative pain, cognitive dysfunction (POCD), hospital stay, and recovery quality in liver cancer patients undergoing hepatectomy.

A retrospective analysis of 80 liver cancer patients was conducted, categorized by analgesic adequacy, pain recovery, and POCD incidence: adequate vs. inadequate analgesia (n=50 vs. n=30), favorable vs. delayed pain recovery (n=36 vs. n=44), and POCD vs. non-POCD (n=42 vs. n=38). Based on these results, a prospective study (April 2024-April 2025) enrolled patients scheduled for elective hepatectomy, assigned to the GA group (n=59) or GEA group (n=47). Primary outcomes included intraoperative analgesic consumption, postoperative VAS pain scores, MoCA cognitive scores, hospital stay length, and adverse event rates.

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Key information

About this study

Compared to GA alone, combined epidural-general anesthesia provides better perioperative pain control, reduces POCD risk, shortens hospitalization, and enhances recovery. GEA is a preferable anesthetic approach for liver cancer surgery.

Who can participate

Healthy volunteers accepted: No

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

  • Inclusion Criteria:
  • Histologically or radiologically confirmed primary liver cancer (HCC or cholangiocarcinoma)
  • Scheduled for elective open or laparoscopic radical hepatectomy
  • Age 18-75 years
  • ASA Physical Status I-III
  • Child-Pugh class A or B liver function
  • Normal preoperative MoCA score (≥26)
  • Willing to participate and provide informed consent
  • Exclusion Criteria:
  • Severe cardiovascular, pulmonary or renal disease (ASA IV/V)
  • Chronic pain disorders or preoperative opioid use (>3 months)
  • Known neurologic/psychiatric conditions (dementia, stroke, epilepsy)
  • Concurrent major procedures (e.g., vascular resection)
  • Intraoperative conversion to palliative surgery
  • Massive intraoperative hemorrhage (>2000 mL)
  • Coagulopathy (INR >1.5 or platelets <50×10⁹/L)
  • Spinal abnormalities precluding epidural catheterization
  • Pregnancy or lactation
  • Allergy to local anesthetics or study medications

Treatment and study plan

General Anesthesia (GA) group

Drug

In the General Anesthesia (GA) group (n = 59), patients received combined intravenous-inhalation general anesthesia. Anesthesia induction was performed using propofol and remifentanil, followed by maintenance with sevoflurane to ensure adequate anesthetic depth and hemodynamic stability throughout the procedure.

General-Epidural Anesthesia (GEA) group

Drug

In the General-Epidural Anesthesia (GEA) group (n = 47), patients received the same general anesthesia protocol as the GA group, in addition to epidural anesthesia. An epidural catheter was placed preoperatively at the T7-T9 vertebral level using a midline approach under strict aseptic conditions. Following successful catheterization and confirmation of proper placement, a continuous intraoperative infusion of 0.25% ropivacaine was administered via the epidural route to provide segmental analgesia and reduce intraoperative opioid requirements.

Primary outcomes

  1. Postoperative Cognitive Dysfunction (POCD)

    Time frame: Baseline (preoperative), POD1 (24±4h), POD3 (72±6h)

    Percentage of patients with:

    MoCA score <26 at postoperative assessment OR

    ≥2-point decrease from preoperative baseline (Assessed using Montreal Cognitive Assessment, 30-point scale)

  2. Postoperative Pain Intensity

    Time frame: 2h, 6h, 12h, 24h, 48h postoperatively

    Mean pain scores measured by:

    Visual Analog Scale (VAS)

    10cm scale (0=no pain, 10=worst pain)

Secondary outcomes

  1. Intraoperative Opioid Consumption

    Time frame: Anesthesia induction to extubation

    Total remifentanil dose administered:

    Measured in micrograms (μg)

    Recorded from anesthesia machine

  2. Hospital Length of Stay

    Time frame: Up to 30 days post-surgery

    Duration from surgery end to discharge:

    Measured in days

    From electronic medical records

  3. Adverse Event Incidence

    Time frame: 0-72 hours postoperatively

    Percentage of patients with:

    Nausea/vomiting

    Delirium (CAM-positive)

    Other complications

Other outcomes

  1. Intraoperative Analgesic Adequacy

    Time frame: Entire surgical duration

    Percentage of patients with:

    Grade I (adequate) vs

    Grades II-IV (inadequate) analgesia (Per Supplementary Table S1 criteria)

  2. Surgical Stress Correlation

    Time frame: Intraoperative period

    Pearson correlation coefficients between:

    Anesthesia technique (GA/GEA)

    Blood loss (mL)

    Surgery duration (min)

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital, Qingchun Campus, Zhejiang University School of Medicine,

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2025
Registry last updated
Jul 31, 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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