Clinical trial NCT02192879: TEA vs. PVB vs. PCA in Liver Resection Surgery
Official title: A Comparison of the Efficacy of Alternative Analgesia Modalities in Complex Hepatic Resection Surgery: Thoracic Epidural Analgesia Versus Continuous Paravertebral Block With Patient-Controlled Analgesia Versus Patient-Controlled Analgesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain Management Strategies in Liver Resection Surgery
Keywords: thoracic epidural
continuous paravertebral catheter
PCA
liver resection
pain management
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-07-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Highest VAS Pain Score at Rest
timeFrame: postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise
measure: Gastrointestinal Recovery
timeFrame: postoperatively until return of bowel function, up to 7 days
measure: Cumulative Postoperative Opioid Requirement
timeFrame: 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
measure: Incidence of Major Postoperative Complication
timeFrame: time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise
measure: Highest VAS Pain Scores With Coughing
timeFrame: postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days
Other outcomes:
measure: Serious Adverse Events Associated With Regional Catheter Placement
timeFrame: postoperatively until removal of regional catheter removed, with an average of 3 days up to 7 days
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Elizabeth B Malinzak, MD
role: PRINCIPAL_INVESTIGATOR
References: