TEA vs. PVB vs. PCA in Liver Resection Surgery

NCT02192879 | Terminated Results DMC

• 1 other identifier: Pro00042166
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management Strategies in Liver Resection Surgery

Keywords

thoracic epidural; continuous paravertebral catheter; PCA; liver resection; pain management

Outcome Measures

Primary Outcomes (1)

• Highest VAS Pain Score 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. 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).

  postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days

Secondary Outcomes (5)

• 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

• Gastrointestinal Recovery

  postoperatively until return of bowel function, up to 7 days

• 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

• 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

• Highest VAS Pain Scores With Coughing

  postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days

Other Outcomes (1)

• Serious Adverse Events Associated With Regional Catheter Placement

  postoperatively until removal of regional catheter removed, with an average of 3 days up to 7 days

Study Arms (3)

Thoracic Epidural

ACTIVE COMPARATOR

Device: thoracic epidural

Continuous Paravertebral Catheter

ACTIVE COMPARATOR

Device: continuous paravertebral catheter

Patient-Controlled Analgesia

ACTIVE COMPARATOR

Drug: Patient-Controlled Analgesia

Interventions

thoracic epidural DEVICE

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).

Thoracic Epidural

continuous paravertebral catheter DEVICE

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.

Continuous Paravertebral Catheter

Patient-Controlled Analgesia DRUG

Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.

Patient-Controlled Analgesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>/= 18 years and \</= 80 years
• Scheduled for elective hepatic resection surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Limitations and Caveats

Unable to recruit adequate number of participants, and decision was made to terminate the study.

Results Point of Contact

• Title: Elizabeth Malinzak, MD
• Organization: Duke University Medical Center

elizabeth.malinzak@duke.edu

919-681-9660

Study Officials

• Elizabeth B Malinzak, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: July 17, 2014
• Study Start: August 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 24, 2016
• Results First Posted: September 12, 2016

Record last verified: 2016-09

Locations

US (1)