TEA vs. PVB vs. PCA in Liver Resection Surgery

Not Applicable

Terminated

Conditions: Pain Management Strategies in Liver Resection Surgery

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

Registration Number: NCT02192879

Lead Sponsor: Duke University

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 10

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient-Controlled Analgesia	Patient-Controlled Analgesia	-
Thoracic Epidural	thoracic epidural	-
Continuous Paravertebral Catheter	continuous paravertebral catheter	-

Primary Outcome Measures

Name	Time	Method
Highest VAS Pain Score at Rest	postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days	Post-operative pain scores at rest, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be the primary outcome measured. Pain scores will be collected per standard PACU protocol (every 60 minutes) and on the hospital ward at hours 2, 4, 6 and 12, and then daily until day 3 or when the epidural/paravertebral catheter is removed. Postoperative pain at rest will be defined as the highest VAS pain score reported by each patient at any time. Pain score is from 0 (no hurt) to 10 (hurts worst).

Secondary Outcome Measures

Name	Time	Method
Hospital Length of Stay	time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise	Hospital length of stay will be recorded for each of the 3 groups to see if there is a statistical difference between groups.
Gastrointestinal Recovery	postoperatively until return of bowel function, up to 7 days	Postoperative return of bowel function and time to first feeding will be recorded for each of the 3 groups.
Incidence of Major Postoperative Complication	time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise	Major surgical, infectious, respiratory, cardiac, and renal complications will be recorded for subjects in each arm of the study.
Highest VAS Pain Scores With Coughing	postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days	Post-operative pain scores with coughing, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be measured. Pain score is from 0 (no hurt) to 10 (hurts worst).
Cumulative Postoperative Opioid Requirement	postpoperatively until regional catheter removed or subjects transitioned to an oral pain management regimen, an expected average of 3 days and up to 7 days	Cumulative postoperative opioid use in morphine equivalents will be recorded for subjects in the 3 arms of the study. The investigators hypothesize that the TEA and/or PVB arms may show less opioid use over PCA.