TEA vs. PVB vs. PCA in Liver Resection Surgery
|ClinicalTrials.gov Identifier: NCT02192879|
Recruitment Status : Terminated (Unable to recruit subjects)
First Posted : July 17, 2014
Results First Posted : September 12, 2016
Last Update Posted : October 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pain Management Strategies in Liver Resection Surgery||Device: thoracic epidural Device: continuous paravertebral catheter Drug: Patient-Controlled Analgesia||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||August 2014|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
|Active Comparator: Thoracic Epidural||
Device: thoracic epidural
Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
|Active Comparator: Continuous Paravertebral Catheter||
Device: continuous paravertebral catheter
Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
|Active Comparator: Patient-Controlled Analgesia||
Drug: Patient-Controlled Analgesia
Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
- Highest VAS Pain Score at Rest [ Time Frame: 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).
- Hospital Length of Stay [ Time Frame: 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 [ Time Frame: 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.
- Cumulative Postoperative Opioid Requirement [ Time Frame: 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.
- Incidence of Major Postoperative Complication [ Time Frame: 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 [ Time Frame: 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).
- Serious Adverse Events Associated With Regional Catheter Placement [ Time Frame: postoperatively until removal of regional catheter removed, with an average of 3 days up to 7 days ]Serious adverse events in the 2 arms with regional catheters (TEA and PVB) will be monitored
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192879
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Elizabeth B Malinzak, MD||Duke University|