Analgesic Efficacy After Pancreatobiliary Surgery: Intravenous Versus Patient-controlled Epidural
Primary Purpose
Pancreatic Cancer, Biliary Tract Neoplasms
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Patient-controlled analgesia
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- Pancreatobiliary malignancies
- Anticipating open surgery
- Written concent
Exclusion Criteria:
- History of previous upper abdominal open surgery
- Psychiatric problems
- Cognitive impairment
- Chronic pain
Elimination Criteria
- Rejected written concent
- Failure to follow instructions of doctor
- Stopped surgery due to peritoneal metastasis
Sites / Locations
- National Cancer Center
- National Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A (IV-PCA group)
B (PCEA group)
Arm Description
IV-PCA drug: Fentanyl 3000 mcg and Oxycodone 100 mg were mixed Normal saline 200 ml
PCEA drug: Morphine 5 mg and Ropivacaine 750 mg were mixed Normal saline 400 ml loading of preadministered Morphine 1 mg and Ropivacaine 11.25 mg
Outcomes
Primary Outcome Measures
Comparison of analgesic efficacy after major surgery in pancreatobiliary cancers: Intravenous patient-controlled analgesia versus patient-controlled epidural analgesia
Comparison of pain scale (Numeric rating scale; minimum: 0, maximum: 10) of IV PCA and PCEA during ambulation on the day 2 postoperatively; Scale 0 means no pain and scale 10 means most painful
Secondary Outcome Measures
Investigation and comparison of pain and clinical progress during rest after surgery, side effects of drugs administered to IV-PCA and PCEA, and complications related to PCEA procedure
Comparison of pain scale (Numeric rating scale; minimum: 0, maximum: 10) of IV PCA and PCEA during rest from the day 1 to 7 postoperatively; comparison of amount of totally infused analgesics, serum level of troponin I on the day 1 postoperatively, and incidence of postoperative complications between the two groups; investigation of PCEA-related complications and adverse effects of analgesics
Full Information
NCT ID
NCT04352023
First Posted
April 2, 2020
Last Updated
April 15, 2020
Sponsor
National Cancer Center, Korea
1. Study Identification
Unique Protocol Identification Number
NCT04352023
Brief Title
Analgesic Efficacy After Pancreatobiliary Surgery: Intravenous Versus Patient-controlled Epidural
Official Title
Comparison of Analgesic Efficacy After Major Surgery in Pancreatobiliary Cancers: Intravenous Patient-controlled Analgesia Versus Patient-controlled Epidural Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective, single institute based, open label, double arm, randomized controlled trial Hypothesis: Pain control after resection of hepatobiliary tumors in patients with PCEA is more effective than in patients with IV-PCA.
Detailed Description
Postoperative pain control is important in helping patients who underwent abdominal surgery to recover and to live a normal life. There is a method of administering painless injections to relieve postoperative pain. Currently, IV-PCA is mostly used. However, this method has a disadvantage in that the dosage of the opioid-based analgesic is increased, and thus side effects may be concerned. By administering analgesics through an epidural route approached through the thoracic vertebrae rather than intravenous injection, effective post-operative pain control and less side effects can be expected in lesser amounts. This study prospectively compared the pain control effects of IV-PCA and PCEA in patients undergoing resection of hepatobiliary tumors at the National Cancer Center, revealing that PCEA is more effective in alleviating pain after surgery. It has a purpose. In addition, the investigators will investigate and compare clinical outcomes (first fart, dietary progression, postoperative complications, etc.) of the two patient groups and investigate the side effects of PCEA and complications related to the procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Biliary Tract Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial, prospective, single institute Experimental: A IV-PCA group IV-PCA drug: Fentanyl 3000 mcg and Oxycodone 100 mg were mixed Normal saline 200 ml Procedure/Surgery: Patient-controlled analgesia Intravenous patient-controlled analgesia Patient-controlled epidural analgesia
Experimental: B PCEA group PCEA drug: Morphine 5 mg and Ropivacaine 750 mg were mixed Normal saline 400 ml loading of preadministered Morphine 1 mg and Ropivacaine 11.25 mg Procedure/Surgery: Patient-controlled analgesia Intravenous patient-controlled analgesia Patient-controlled epidural analgesia
Masking
ParticipantCare ProviderInvestigator
Masking Description
2, 4, 6 block randomization
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A (IV-PCA group)
Arm Type
Experimental
Arm Description
IV-PCA drug: Fentanyl 3000 mcg and Oxycodone 100 mg were mixed Normal saline 200 ml
Arm Title
B (PCEA group)
Arm Type
Experimental
Arm Description
PCEA drug: Morphine 5 mg and Ropivacaine 750 mg were mixed Normal saline 400 ml
loading of preadministered Morphine 1 mg and Ropivacaine 11.25 mg
Intervention Type
Procedure
Intervention Name(s)
Patient-controlled analgesia
Intervention Description
Intravenous patient-controlled analgesia Patient-controlled epidural analgesia
Primary Outcome Measure Information:
Title
Comparison of analgesic efficacy after major surgery in pancreatobiliary cancers: Intravenous patient-controlled analgesia versus patient-controlled epidural analgesia
Description
Comparison of pain scale (Numeric rating scale; minimum: 0, maximum: 10) of IV PCA and PCEA during ambulation on the day 2 postoperatively; Scale 0 means no pain and scale 10 means most painful
Time Frame
Day 2 postoperatively
Secondary Outcome Measure Information:
Title
Investigation and comparison of pain and clinical progress during rest after surgery, side effects of drugs administered to IV-PCA and PCEA, and complications related to PCEA procedure
Description
Comparison of pain scale (Numeric rating scale; minimum: 0, maximum: 10) of IV PCA and PCEA during rest from the day 1 to 7 postoperatively; comparison of amount of totally infused analgesics, serum level of troponin I on the day 1 postoperatively, and incidence of postoperative complications between the two groups; investigation of PCEA-related complications and adverse effects of analgesics
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pancreatobiliary malignancies
Anticipating open surgery
Written concent
Exclusion Criteria:
History of previous upper abdominal open surgery
Psychiatric problems
Cognitive impairment
Chronic pain
Elimination Criteria
Rejected written concent
Failure to follow instructions of doctor
Stopped surgery due to peritoneal metastasis
Facility Information:
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
410-769
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
3 years from the study completion date
Learn more about this trial
Analgesic Efficacy After Pancreatobiliary Surgery: Intravenous Versus Patient-controlled Epidural
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