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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01438476
First received: September 20, 2011
Last updated: June 11, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Mean Postoperative Pain Scores [ Time Frame: 5 Days postoperative ] [ Designated as safety issue: No ]
    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: 200
Study Start Date: January 2012
Estimated Primary Completion Date: January 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438476

Contacts
Contact: Jean-Nicolas Vauthey, MD 713-792-6940

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01438476     History of Changes
Other Study ID Numbers: 2011-0146, NCI-2011-03284
Study First Received: September 20, 2011
Last Updated: June 11, 2014
Health Authority: United States: Institutional Review Board

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:
Liver Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 29, 2014