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Comparison of the effects of erector spinae plane block and intravenous patient-controlled analgesia on the analgesic effect and immune function after open liver surgery: a randomized controlled non-inferiority trial

Comparison of the effects of erector spinae plane block and intravenous patient-controlled analgesia on the analgesic effect and immune function after open liver surgery: a randomized controlled non-inferiority trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029998
Enrollment
Unknown
Registered
2020-02-19
Start date
2020-02-28
Completion date
Unknown
Last updated
2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver carcinoma

Interventions

Intravenous analgesia group:intravenous patient-controlled analgesia
Erect spinae plane block group:patient-controlled analgesia with erect spinae plane block

Sponsors

Zhongshan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients with open liver resection due to hepatocellular liver cancer; (2) Patients with preoperative coagulation function abnormalities: international standardized ratio (INR) s >= 1.4, platelet count 38s; (3) The anesthesiologist has concerns about the coagulation function and considers it inappropriate to do epidural punctures; (4) Patients have sufficient language communication ability to complete postoperative follow-up; (5) Patients are voluntary and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Aged 80 years; (2) History of local anesthetic allergy; (3) Long-term opioid analgesia due to chronic pain; (4) Joint surgery (except gallbladder resection); (5) Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
The average resting NRS score for all follow-up points, including the day of surgery and postoperative 3 days.;

Secondary

MeasureTime frame
Average daily NRS score for postoperative 3 days (rest/cough);Total daily retrieve medication dosage for postoperative 3 days;Adverse effects related to analgesia of postoperative 3 days (itching, nausea and vomiting, urinary retention);Incidence of low blood pressure associated with analgesia within postoperative 3 days;Patient satisfaction with pain management;Incidence of acute kidney injury(AKI): AKI diagnosed according to the AKIN acute kidney injury diagnostic criteria;Incidence of postoperative complications to varying degrees: determined by the Accordion grading system of surgical complications;Changes in postoperative cellular immune function: draw peripheral blood (approximately 3 ml) to detect the activity percentage of T-cell subgroup CD3+, CD4+, CD8+T lymphocytes and NK cells (CD3 -/CD16+CD56+) at preoperative, 24h postoperative and 72h postoperative;Changes in coagulation function postoperatively: draw peripheral blood to detect the patient's coagulation function at preoperative, postoperative 24h, 72h;The liver tumor development;The time between the operation day and the time to meet the discharge criteria which is determined by the attending physician;Anesthesia costs, total costs during hospitalization;Mortality rate of the postoperative 30-day;

Countries

China

Contacts

Public ContactZhang Xiaoguang
zhang.xiaoguang@zs-hospital.sh.cn+86 13641995773

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026