Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-Controlled Analgesia For Liver and/or Pancreas
Randomized Controlled Trial of Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient Controlled Analgesia (3:1) in Patients Undergoing Liver and/or Pancreatic Resection
2 other identifiers
interventional
178
1 country
1
Brief Summary
The goal of this clinical research study is to learn if there is a difference in patients' quality of recovery if they receive 1 of 2 standard kinds of pain control treatments after surgery on the liver and/or pancreas. Researchers want to learn which method helps people to recover more completely and more quickly after surgery. The 2 kinds of pain control are intravenous (IV) pain management and epidural pain management.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2012
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2011
CompletedFirst Posted
Study publicly available on registry
September 22, 2011
CompletedStudy Start
First participant enrolled
January 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2017
CompletedResults Posted
Study results publicly available
February 12, 2020
CompletedFebruary 12, 2020
February 1, 2020
5.7 years
September 20, 2011
January 23, 2020
February 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative Pain Experience
The Area Under the Curve (AUC) pain score during the first 48 hours after surgery. Post operative pain was measured during the first 48 hours per unit acuity guidelines. Typically this was at a minimum of every four hours yielding an average number of measures during the first 48 hours. The scale is 0-480 low scores are better.
First 48 hours after surgery
Study Arms (2)
IV Pain Management
EXPERIMENTALIntravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Epidural Pain Management
EXPERIMENTALThoracic epidurals placed preoperatively in either holding area or in operating room. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Interventions
Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures.
Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room.
Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Hourly post surgery rating level of pain on a scale of 0-10.
Eligibility Criteria
You may qualify if:
- Patients undergoing liver and/or pancreatic surgical resection for malignancy at MD Anderson Cancer Center.
- Patients 18 years of age and older. There will be no upper age restriction.
- Patients must sign a study-specific consent form.
- Adequate coagulation function within 30 days of surgery: Platelets \>/= 100,000/ml; international normalized ratio (INR) \</= 1.5; activated partial thromboplastin time (aPTT) \</= 40.
- Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude epidural placement.
You may not qualify if:
- Evidence of severe uncontrolled systemic disease or other comorbidity that precludes liver or pancreatic surgery.
- History of chronic pain, long-term narcotic use or being considered for chronic pain consultation postoperatively.
- Anaphylaxis to local anesthetics or narcotics.
- Previous or current neurologic disease affecting the lower hemithorax or below.
- Major open abdominal/thoracic surgery in the previous 30 days under general anesthesia, except for total intravenous anesthesia (TIVA).
- Technical contraindications to epidural placement: previous thoracic spinal surgery or local skin or soft tissue infection at proposed site for epidural insertion.
- Ongoing use or planned peri-operative use of anticoagulants (not including deep vein thrombosis (DVT) prophylaxis).
- Known bleeding diathesis or coagulopathy.
- Educational, psychiatric (untreated or poorly controlled schizophrenia, major depression, or bipolar disorder), or communication (language) barrier that would preclude accurate assessment of postoperative pain and/or ability to answer questionnaires (need to be able to read, comprehend, and answer questions).
- Inability to comply with study and/or follow-up procedures.
- Patient refusal to participate in randomization.
- Pregnant women are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 12 consecutive months) must agree to practice adequate contraception and to refrain from breast-feeding, as specified in the informed consent.
- Patients with obvious unresectable disease prior to signing informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (2)
Cata JP, Velasquez JF, Ramirez MF, Vauthey JN, Gottumukkala V, Conrad C, Kim BJ, Aloia T. Inflammation and pro-resolution inflammation after hepatobiliary surgery. World J Surg Oncol. 2017 Aug 10;15(1):152. doi: 10.1186/s12957-017-1220-6.
PMID: 28807031DERIVEDAloia TA, Kim BJ, Segraves-Chun YS, Cata JP, Truty MJ, Shi Q, Holmes A, Soliz JM, Popat KU, Rahlfs TF, Lee JE, Wang XS, Morris JS, Gottumukkala VNR, Vauthey JN. A Randomized Controlled Trial of Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-controlled Analgesia After Major Hepatopancreatobiliary Surgery. Ann Surg. 2017 Sep;266(3):545-554. doi: 10.1097/SLA.0000000000002386.
PMID: 28746153DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jean-Nicolas Vauthey,MD/Professor, Surgical Oncology
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Nicolas Vauthey, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2011
First Posted
September 22, 2011
Study Start
January 26, 2012
Primary Completion
October 18, 2017
Study Completion
October 18, 2017
Last Updated
February 12, 2020
Results First Posted
February 12, 2020
Record last verified: 2020-02