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

NCT07097220 | Completed

• 1 other identifier: No. 2025-0355
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cancer; Hepatectomy; Anesthesia Techniques; Postoperative Pain; Cognitive Dysfunction; Epidural-general Anesthesia

Outcome Measures

Primary Outcomes (2)

• Postoperative Cognitive Dysfunction (POCD)

  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)

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

• Postoperative Pain Intensity

  Mean pain scores measured by: Visual Analog Scale (VAS) 10cm scale (0=no pain, 10=worst pain)

  2h, 6h, 12h, 24h, 48h postoperatively

Secondary Outcomes (3)

• Intraoperative Opioid Consumption

  Anesthesia induction to extubation

• Hospital Length of Stay

  Up to 30 days post-surgery

• Adverse Event Incidence

  0-72 hours postoperatively

Other Outcomes (2)

• Intraoperative Analgesic Adequacy

  Entire surgical duration

• Surgical Stress Correlation

  Intraoperative period

Study Arms (2)

general anesthesia group

EXPERIMENTAL

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.

Drug: General Anesthesia (GA) group

General-Epidural Anesthesia group

EXPERIMENTAL

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.

Drug: General-Epidural Anesthesia (GEA) group

Interventions

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 anesthesia group

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.

General-Epidural Anesthesia group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310015, China

Location

MeSH Terms

Conditions

Liver Neoplasms; Pain, Postoperative; Cognitive Dysfunction

Interventions

Anesthesia, General; Population Groups

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 31, 2025
• Study Start: May 16, 2025
• Primary Completion: June 13, 2025
• Study Completion: June 15, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-06

Locations

CN (1)