Hepatic Resection, Liver Cancer, Liver Neoplasms
Conditions
Keywords
Postoperative Pain, Acute Pain, Hepatic Resection
Brief summary
Background: Open liver resection is associated with severe postoperative pain. While thoracic epidural analgesia (TEA) is considered the gold standard for pain control, its clinical application is often limited by postoperative coagulation profile derangement, which increases the risk of epidural hematoma. Continuous erector spinae plane block (ESPB) has emerged as a promising, safer alternative with a lower risk of bleeding complications. Objective: This study aims to compare the postoperative analgesic efficacy, safety profiles, and impacts on respiratory function between ultrasound-guided continuous ESPB and TEA in patients undergoing elective open liver resection. Hypothesis: The investigators hypothesize that continuous ESPB using a programmed intermittent bolus (PIB) regimen is non-inferior to TEA regarding 72-hour postoperative pain scores at rest, while offering superior hemodynamic stability and fewer technique-related risks.
Detailed description
This is a randomized, controlled, parallel-group, non-inferiority clinical trial conducted at Bach Mai Hospital. Eligible patients scheduled for elective open liver resection will be randomly allocated into one of two groups at a 1:1 ratio: 1. ESPB Group (n = 30): Patients will receive bilateral erector spinae plane catheters placed at the T7 level under ultrasound guidance prior to anesthesia induction. A bolus of 20 mL Ropivacaine 0.2% will be administered on each side. Postoperative analgesia will be maintained for 72 hours using a Programmed Intermittent Bolus (PIB) regimen of Ropivacaine 0.1%: 24 mL every 3 hours on the right side and 12 mL every 3 hours on the left side. 2. TEA Group (n = 30): Patients will receive a thoracic epidural catheter inserted at the T7-T8 interspace. An initial bolus of 10 mL Ropivacaine 0.1% will be given, followed by a continuous basal infusion of Ropivacaine 0.1% at 5-8 mL/h for 72 hours. Multimodal Analgesia: All patients in both groups will receive a standardized general anesthesia protocol and systemic multimodal analgesia, including intravenous paracetamol (1 g every 6 hours) and nefopam (20 mg every 6 hours). Outcomes Evaluation: The primary outcome is the postoperative pain intensity measured by the Numerical Rating Scale (NRS) at rest 24 hours after surgery. Secondary outcomes include NRS pain scores at rest and during coughing at multiple time points up to 72 hours, cumulative 24-hour morphine consumption, hemodynamic parameters, and incidence of adverse events (e.g., hypotension, postoperative nausea and vomiting, hematoma, or catheter failure)
Interventions
Patients will receive ultrasound-guided continuous bilateral erector spinae plane block at the T7 level with a programmed intermittent bolus (PIB) regimen of Ropivacaine 0.1% (18 mL/3h on the right side and 18 mL/3h on the left side) for 72 hours postoperatively, combined with systemic multimodal analgesia
PROCEDUREThoracic Epidural Analgesia (TEA)
Patients will receive a thoracic epidural catheter inserted at the T7-T8 interspace with a continuous basal infusion of Ropivacaine 0.1% at a rate of 5-8 mL/h for 72 hours postoperatively, combined with systemic multimodal analgesia
Sponsors
Nguyen Toan Thang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* \* Patients aged between 18 and 80 years old. * American Society of Anesthesiologists (ASA) physical status classification I to III. * Scheduled to undergo elective open liver resection (open hepatectomy). * Patient provides written informed consent to participate in the study.
Exclusion criteria
* Severe coagulation profile derangement prior to surgery (defined as International Normalized Ratio \[INR\] \> 1.5 or 2.0, or Platelet count \[PLT\] \< 50 G/L or 100 G/L). * Severe hepatic impairment (Child-Pugh Class C). * Severe chronic obstructive pulmonary disease (COPD GOLD stage III-IV). * Severe cardiac dysfunction with an ejection fraction (EF) \< 35%. * Severe obesity with a Body Mass Index (BMI) \> 40 kg/m². * Localized infection at the planned puncture/needle insertion site. * Known allergy or hypersensitivity to local anesthetics (e.g., Ropivacaine) or opioids (e.g., Morphine). * Pregnancy or current lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity at Rest at 24 Hours | At 24 hours postoperatively | Postoperative pain intensity evaluated using the Numerical Rating Scale (NRS), where 0 represents no pain and 10 represents the worst imaginable pain. The score will be recorded at rest exactly 24 hours after the completion of the surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Morphine Equivalent Consumption | From 0 to 24 hours postoperatively | The total amount of intravenous morphine equivalents (in milligrams) administered as rescue analgesia to the patient during the first 24 hours after surgery |
| Postoperative Pain Intensity at Rest and During Coughing up to 72 Hours | At 0, 1, 3, 6, 12, 48, and 72 hours postoperatively | Pain intensity scores assessed using the Numerical Rating Scale (NRS, 0-10) both at rest and during coughing at multiple scheduled postoperative time intervals |
| Incidence of Postoperative Complications and Adverse Events | Up to 72 hours postoperatively | The percentage of patients experiencing technique-related complications (such as local hematoma, catheter dislodgement, block failure) or opioid-related side effects (including postoperative nausea and vomiting, pruritus, urinary retention), as well as pulmonary complications (atelectasis, pneumonia) and hemodynamic instability (hypotension, bradycardia) |
| Time to Gastrointestinal Recovery | Up to 72 hours postoperatively | Evaluation of bowel function recovery, measured by the time (in hours) from the end of surgery to the first passage of flatus (first anal exhaust), and the time (in hours) to the first tolerance of oral intake (solid or liquid food) |
| First Postoperative Night Sleep Quality | On the first postoperative night | The patient's subjective sleep quality during the first night after surgery, evaluated using a visual analog scale (VAS for sleep) or the Pittsburgh Sleep Quality Index (PSQI) subscale, where sleep disruption and total sleep duration are assessed |
| Postoperative Length of Hospital Stay | From the day of surgery to hospital discharge (estimated up to 14 days) | The total number of days from the completion of the surgical procedure to the day the patient is officially discharged from the hospital, meeting predefined standard discharge criteria |
Countries
Vietnam
Outcome results
None listed