TEA vs. PVB vs. PCA in Liver Resection Surgery

Duke University

Status: Terminated

Conditions: Pain Management Strategies in Liver Resection Surgery

Treatments: Device: thoracic epidural; Drug: Patient-Controlled Analgesia; Device: continuous paravertebral catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02192879

Pro00042166

Details and patient eligibility

About

This study aims to compare the efficacy and safety of three alternative methods of analgesia in patients undergoing complex liver resection surgery: 1) thoracic epidural analgesia (TEA), 2) continuous paravertebral block (PVB) with patient-controlled analgesia (PCA) and 3) patient-controlled analgesia (PCA) alone. Regional anesthesia techniques such as TEA and PVB may improve recovery and decrease postoperative pain scores in addition to other benefits such earlier return of bowel function and shortened length of hospital stay, although some practitioners have voiced concerns about the safety and efficacy of these techniques in patients after liver resection who may develop postoperative coagulation abnormalities. The investigators plan to enroll a total of 150 patients (adults >/= 18 years of age who meet study criteria) scheduled for complex liver resection surgery in this study, who will then be randomized into 50 patients per arm of the study (3 total arms). Postoperative pain scores will be collected in PACU and throughout the patient's hospital stay as well as routine blood tests including complete blood count, coagulation labs (PT/INR, aPTT) and serum creatinine to measure renal function. The study team will also collect additional data prospectively on all patients enrolled in the study; these parameters will include age, sex, type of operation performed, length of operation, volume of intraoperative blood loss, volume of intraoperative fluid administration including blood products, daily postoperative intravenous fluid administration, length of time to first feeding, day of epidural catheter removal, length of hospital stay and incidence of major postoperative complications (surgical, respiratory, cardiac, renal, etc.). Once primary and secondary data points are obtained, the data will undergo rigorous statistical analysis using the appropriate statistical techniques to determine the outcomes. The investigators propose that epidural and/or paravertebral analgesia may improve recovery times and decrease hospital length of stay, which would be beneficial for the patient as well as decrease hospital costs. In addition, if better postoperative pain management scores can be achieved with epidural or paravertebral analgesia, and no significant prolonged postoperative coagulopathy is associated with patients undergoing major hepatic resection surgical procedures, these regional analgesia strategies can be considered a safe option for pain management in this patient population.

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >/= 18 years and </= 80 years
• Scheduled for elective hepatic resection surgery

Exclusion criteria

• Preexisting coagulopathy (INR >1.5)
• Spinal stenosis
• Local infection in area where catheter will be inserted
• Severe cardiovascular disease (NYHA Class III/IV)
• Severe pulmonary disease (FEV1 <50% of predicted value)
• Allergy or sensitivity to narcotics or local anesthetics
• BMI >45
• Inability to give informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

Thoracic Epidural

Active Comparator group

Treatment:

Device: thoracic epidural

Continuous Paravertebral Catheter

Active Comparator group

Treatment:

Device: continuous paravertebral catheter

Patient-Controlled Analgesia

Active Comparator group

Treatment:

Drug: Patient-Controlled Analgesia