Liver CancerNCT07097220
Effects of Different Anesthetic Techniques on Intraoperative and Postoperative Pain Levels and Cognitive Function in Patients Undergoing Hepatectomy for Liver Cancer
A study testing General Anesthesia (GA) group and General-Epidural Anesthesia (GEA) group in people with Liver Cancer and Hepatectomy, run by Sir Run Run Shaw Hospital, Qingchun Campus, Zhejiang University School of Medicine, at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cancer, Hepatectomy, Anesthesia Techniques
- What is being tested?
- General Anesthesia (GA) group and General-Epidural Anesthesia (GEA) group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2025to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- Coagulopathy (INR >1.5 or platelets <50×10⁹/L)
- Spinal abnormalities precluding epidural catheterization
- Pregnancy or lactation
- Allergy to local anesthetics or study medications
Trial locations and contacts
1 site in 1 country.
China1 site
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310015
About this study
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.
Read the detailed description
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.
- Conditions
- Liver Cancer, Hepatectomy, Anesthesia Techniques, Postoperative Pain, Cognitive Dysfunction, Epidural-general Anesthesia
- Being tested
- General Anesthesia (GA) group, General-Epidural Anesthesia (GEA) group
- Medical subject headings
- Liver Neoplasms, Pain, Postoperative, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Anesthesia (GA) groupDrug
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) groupDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: General-Epidural Anesthesia (GEA) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 2h, 6h, 12h, 24h, 48h postoperatively
Secondary outcomes (3)
Intraoperative Opioid Consumption
Total remifentanil dose administered:
Measured in micrograms (μg)
Recorded from anesthesia machine
Measured: Anesthesia induction to extubation
Hospital Length of Stay
Duration from surgery end to discharge:
Measured in days
From electronic medical records
Measured: Up to 30 days post-surgery
Adverse Event Incidence
Percentage of patients with:
Nausea/vomiting
Delirium (CAM-positive)
Other complications
Measured: 0-72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start16 May 2025
- Primary completion13 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital, Qingchun Campus, Zhejiang University School of Medicine,
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Juhui Chen, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097220
- Sponsor's protocol ID
- No. 2025-0355
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Anesthetic Techniques on Intraoperative and Postoperative Pain Levels and Cognitive Function in Patients Undergoing Hepatectomy for Liver Cancer
- ClinicalTrials.gov ID
- NCT07097220
- Acronym / sponsor ID
- No. 2025-0355
- Conditions
- Liver Cancer, Hepatectomy, Anesthesia Techniques, Postoperative Pain, Cognitive Dysfunction, Epidural-general Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Sir Run Run Shaw Hospital, Qingchun Campus, Zhejiang University School of Medicine,Other government
- Study start
- 16 May 2025 (actual)
- Primary completion
- 13 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| general anesthesia group | Experimental | Drug: General Anesthesia (GA) groupIn 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 group | Experimental | Drug: General-Epidural Anesthesia (GEA) groupIn 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General Anesthesia (GA) groupIn 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 group |
| General-Epidural Anesthesia (GEA) groupIn 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 group |
Primary outcome
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)
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)
3 secondary outcomes
Intraoperative Opioid Consumption
Time frame: Anesthesia induction to extubation
Hospital Length of Stay
Time frame: Up to 30 days post-surgery
Adverse Event Incidence
Time frame: 0-72 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Anesthesia (GA) group and General-Epidural Anesthesia (GEA) group in people with Liver Cancer and Hepatectomy, run by Sir Run Run Shaw Hospital, Qingchun Campus, Zhejiang University School of Medicine, at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Cognitive Dysfunction (POCD) (time frame: Baseline (preoperative), POD1 (24±4h), POD3 (72±6h)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.