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Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-Controlled Analgesia For Liver and/or Pancreas

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01438476
First Posted: September 22, 2011
Last Update Posted: September 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

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.


Condition Intervention Phase
Liver Cancer Pancreatic Cancer Procedure: Intravenous Patient-Controlled Analgesia (IVPCA) Procedure: Thoracic Epidural Analgesia (TEA) Behavioral: Questionnaires Behavioral: Pain Assessment Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient Controlled Analgesia (3:1) in Patients Undergoing Liver and/or Pancreatic Resection

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Mean Postoperative Pain Scores [ Time Frame: 5 Days postoperative ]
    Pain scores averaged for each participant, and compared between thoracic epidural analgesia (TEA) and intravenous patient controlled analgesia (IVPCA) groups at specific time points as follows: pain scores for the first 6 hours after surgery, pain scores for the next 18 hours after surgery, pain scores for each subsequent 24 hour period after surgery until postoperative day 5 or epidural removed, whichever occurs first. Numeric/Visual Pain Scale (0-10) where 10 is highest level.


Estimated Enrollment: 178
Actual Study Start Date: January 2012
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV Pain Management
Intravenous 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.
Procedure: Intravenous Patient-Controlled Analgesia (IVPCA)
Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures.
Behavioral: Questionnaires
Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Other Name: Survey
Behavioral: Pain Assessment
Hourly post surgery rating level of pain on a scale of 0-10.
Experimental: Epidural Pain Management
Thoracic 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.
Procedure: Thoracic Epidural Analgesia (TEA)
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.
Behavioral: Questionnaires
Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Other Name: Survey
Behavioral: Pain Assessment
Hourly post surgery rating level of pain on a scale of 0-10.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients undergoing liver and/or pancreatic surgical resection for malignancy at MD Anderson Cancer Center.
  2. Patients 18 years of age and older. There will be no upper age restriction.
  3. Patients must sign a study-specific consent form.
  4. Adequate coagulation function within 30 days of surgery: Platelets >/= 100,000/ml; INR </= 1.5; aPTT </= 40.
  5. Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude epidural placement.

Exclusion Criteria:

  1. Evidence of severe uncontrolled systemic disease or other comorbidity that precludes liver or pancreatic surgery.
  2. History of chronic pain, long-term narcotic use or being considered for chronic pain consultation postoperatively.
  3. Anaphylaxis to local anesthetics or narcotics.
  4. Previous or current neurologic disease affecting the lower hemithorax or below.
  5. Major open abdominal/thoracic surgery in the previous 30 days under general anesthesia, except for TIVA (total intravenous anesthesia).
  6. Technical contraindications to epidural placement: previous thoracic spinal surgery or local skin or soft tissue infection at proposed site for epidural insertion.
  7. Ongoing use or planned peri-operative use of anticoagulants (not including DVT prophylaxis).
  8. Known bleeding diathesis or coagulopathy.
  9. 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).
  10. Inability to comply with study and/or follow-up procedures.
  11. Patient refusal to participate in randomization.
  12. 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.
  13. Patients with obvious unresectable disease prior to signing informed consent.
  Contacts and Locations
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): NCT01438476


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Jean-Nicolas Vauthey, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01438476     History of Changes
Other Study ID Numbers: 2011-0146
NCI-2011-03284 ( Registry Identifier: NCI CTRP )
First Submitted: September 20, 2011
First Posted: September 22, 2011
Last Update Posted: September 27, 2017
Last Verified: September 2017

Keywords provided by M.D. Anderson Cancer Center:
Liver Cancer
Pancreatic Cancer
Thoracic epidural analgesia
TEA
Intravenous patient-controlled analgesia
IVPCA
Pain control
Quality of life
QOL
Surgical resection

Additional relevant MeSH terms:
Pancreatic Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Liver Diseases