Back to resultsPatient Controlled Epidural Analgesia Versus Intravenous Patient Controlled Analgesia for Post-Operative Pain Control in Patients Undergoing Elective Liver Resection
Primary Purpose
Liver Cancer, Pain Management
Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
IV PCA
PCEA
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring Epidural Analgesia, Intravenous Patient Controlled, 15-148
Eligibility Criteria
Inclusion Criteria:
- Adults (age 18 years or older) who are able to provide informed consent.
- Patients undergoing open elective liver resection for primary liver pathology (benign or malignant) or secondary metastatic liver disease, including patients undergoing concomitant surgical procedures (such as colorectal resection or debulking procedures), with no contraindication to the insertion of an epidural catheter (localized infection, septicemia, or pre-operative coagulopathy).
Exclusion Criteria:
- Patients with a history of documented anaphylaxis or contraindication to any of the study medications or standardized intra-operative medications. These include dilaudid, fentanyl, and bupivacaine.
- Patients with pain at rest or with movement measured by NRS >2.
- Patients receiving high dose opioids on a chronic basis (greater than or equivalent to 60mg of morphine per day).
- Patients with severe chronic obstructive pulmonary disease (COPD) defined as an FEV1 <50%.
- Patients with significant cognitive impairment or documented psychologic impairment.
- Contraindication to epidural catheter placement including bleeding diathesis (essential thrombocythemia, idiopathic thrombocytopenic purpura, von Willebrand disease, and hemophilia A or B), neurological dysfunction (multiple sclerosis, subacute myelo-opticoneuropathy or preexisting lower limb neurological deficit), prior extensive spinal surgery or major spinal deformity, pre-operative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant in post-operatively, documented pre-operative coagulopathy (INR greater than 1.3 not on Coumadin or PTT greater than 42), platelets less than 100,000/μL, or evidence of infection at potential epidural site.
- Cirrhotic patients. When incidentally discovered intra-operatively, patients will be excluded from the study and replaced, but will be followed for primary and secondary endpoints.
- Patients with poor performance status preoperatively such that they are unable to walk up two flights of stairs.
- Patients taking any opioid agonist/antagonist medication (i.e. Buprenorphine)
Sites / Locations
- Memorial Sloan Kettering Cancer Center (Consent Only)
- Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
IV PCA after surgery
PCEA during and after surgery
Arm Description
general anesthesia with post-operative IV PCA with a standard demand pump
general anesthesia with post-operative thoracic epidural analgesia with a standard demand pump
Outcomes
Primary Outcome Measures
ability to detect a 2-point NRS scale difference
The primary endpoint assesses differences in pain control between PCEA and IV PCA after a "get up and go" test performed on POD2 during pain rounds, evaluated using a NRS pain score.
Secondary Outcome Measures
Full Information
NCT ID
NCT02523443
First Posted
August 12, 2015
Last Updated
September 1, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02523443
Brief Title
Patient Controlled Epidural Analgesia Versus Intravenous Patient Controlled Analgesia for Post-Operative Pain Control in Patients Undergoing Elective Liver Resection
Official Title
A Prospective Randomized Controlled Clinical Trial of Patient Controlled Epidural Analgesia Versus Intravenous Patient Controlled Analgesia for Post-Operative Pain Control in Patients Undergoing Elective Open Liver Resection
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2015 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to learn whether patient-controlled epidural analgesia (PCEA) is a better method for managing pain after liver resection compared to patient-controlled analgesia (IV PCA). Currently, the standard pain control method for liver resection patients is IV PCA. There is not enough data on how epidural (PCEA) relieves pain and movement on a day to day basis after liver resection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Pain Management
Keywords
Epidural Analgesia, Intravenous Patient Controlled, 15-148
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
231 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IV PCA after surgery
Arm Type
Active Comparator
Arm Description
general anesthesia with post-operative IV PCA with a standard demand pump
Arm Title
PCEA during and after surgery
Arm Type
Experimental
Arm Description
general anesthesia with post-operative thoracic epidural analgesia with a standard demand pump
Intervention Type
Other
Intervention Name(s)
IV PCA
Intervention Description
Patients undergoing IV PCA for pain control will have intravenous (IV) analgesia provided through a demand pump started in the recovery room.
Intervention Type
Other
Intervention Name(s)
PCEA
Intervention Description
Patients in this group will have the epidural catheter placed by the anesthesia pain service team in the pre-surgical center (PSC) as performed routinely at MSKCC. The epidural will be used intra-operatively at the end of liver resection phase of the surgical procedure, once the specimen has been extracted, and continued subsequently in the post-operative phase for pain management.
Primary Outcome Measure Information:
Title
ability to detect a 2-point NRS scale difference
Description
The primary endpoint assesses differences in pain control between PCEA and IV PCA after a "get up and go" test performed on POD2 during pain rounds, evaluated using a NRS pain score.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults (age 18 years or older) who are able to provide informed consent.
Patients undergoing open elective liver resection for primary liver pathology (benign or malignant) or secondary metastatic liver disease, including patients undergoing concomitant surgical procedures (such as colorectal resection or debulking procedures), with no contraindication to the insertion of an epidural catheter (localized infection, septicemia, or pre-operative coagulopathy).
Exclusion Criteria:
Patients with a history of documented anaphylaxis or contraindication to any of the study medications or standardized intra-operative medications. These include dilaudid, fentanyl, and bupivacaine.
Patients with pain at rest or with movement measured by NRS >2.
Patients receiving high dose opioids on a chronic basis (greater than or equivalent to 60mg of morphine per day).
Patients with severe chronic obstructive pulmonary disease (COPD) defined as an FEV1 <50%.
Patients with significant cognitive impairment or documented psychologic impairment.
Contraindication to epidural catheter placement including bleeding diathesis (essential thrombocythemia, idiopathic thrombocytopenic purpura, von Willebrand disease, and hemophilia A or B), neurological dysfunction (multiple sclerosis, subacute myelo-opticoneuropathy or preexisting lower limb neurological deficit), prior extensive spinal surgery or major spinal deformity, pre-operative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant in post-operatively, documented pre-operative coagulopathy (INR greater than 1.3 not on Coumadin or PTT greater than 42), platelets less than 100,000/μL, or evidence of infection at potential epidural site.
Cirrhotic patients. When incidentally discovered intra-operatively, patients will be excluded from the study and replaced, but will be followed for primary and secondary endpoints.
Patients with poor performance status preoperatively such that they are unable to walk up two flights of stairs.
Patients taking any opioid agonist/antagonist medication (i.e. Buprenorphine)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vittoria Arslan-Carlon, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center (Consent Only)
City
Basking Ridge
State/Province
New Jersey
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Patient Controlled Epidural Analgesia Versus Intravenous Patient Controlled Analgesia for Post-Operative Pain Control in Patients Undergoing Elective Liver Resection
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