Pain Management Strategies in Liver Resection Surgery Clinical Trial
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
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.
| Status | Terminated |
| Enrollment | 10 |
| Est. completion date | May 2016 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Duke University Medical Center | Durham | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | adverse events associated with regional catheter placement | Adverse events in the 2 arms with regional catheters (TEA and PVB) will be monitored for. The study is not powered for comparing relative safety, especially for very rare adverse events such as epidural hematoma, but we will collect data to help inform future larger scale studies. | postoperatively until removal of regional catheter removed, with an average of 3 days up to 7 days | Yes |
| Primary | Change in Pain Scores at rest | 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. The investigators hypothesize that the TEA and PVB groups may have decreased pain scores over the PCA group. 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. | postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days | No |
| Secondary | hospital length of stay | Hospital length of stay will be recorded for each of the 3 groups to see if there is a statistical difference between groups. | time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise | No |
| Secondary | Gastrointestinal recovery | Postoperative return of bowel function and time to first feeding will be recorded for each of the 3 groups. The investigators hypothesize that if the TEA and/or PVB groups receive less systemic opioid, they may experience less constipation and thus have earlier bowel recovery as evidenced by return of bowel function and oral feeding. | postoperatively until return of bowel function, up to 7 days | No |
| Secondary | cumulative postoperative opioid requirement | Cumulative postoperative opioid use 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. | 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 | No |
| Secondary | incidence of major postoperative complication | Major surgical, infectious, respiratory, cardiac, and renal complications will be recorded for subjects in each arm of the study. | time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise | Yes |
| Secondary | Change in Pain Scores with coughing | 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. The investigators hypothesize that the TEA and PVB groups may have decreased pain scores with coughing over the PCA group. | postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days | No |