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TEA vs. PVB vs. PCA in Liver Resection Surgery

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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
Sponsor:
Information provided by (Responsible Party):
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.

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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192879


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Elizabeth B Malinzak, MD Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02192879     History of Changes
Other Study ID Numbers: Pro00042166
First Posted: July 17, 2014    Key Record Dates
Results First Posted: September 12, 2016
Last Update Posted: October 24, 2016
Last Verified: September 2016

Keywords provided by Duke University:
thoracic epidural
continuous paravertebral catheter
PCA
liver resection
pain management