Pancreatic CancerPhase 2NCT04352023
Analgesic Efficacy After Pancreatobiliary Surgery: Intravenous Versus Patient-controlled Epidural
A Phase 2 study of Pancreatic Cancer and Biliary Tract Neoplasms, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Pancreatic Cancer, Biliary Tract Neoplasms
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2018to 30 Jun 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pancreatobiliary malignancies
- Anticipating open surgery
- Written concent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Analgesic Efficacy After Major Surgery in Pancreatobiliary Cancers: Intravenous Patient-controlled Analgesia Versus Patient-controlled Epidural Analgesia
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.
Read the 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.
- Conditions
- Pancreatic Cancer, Biliary Tract Neoplasms
- Being tested
- Patient-controlled analgesia
- Medical subject headings
- Pancreatic Neoplasms, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-controlled analgesiaProcedure or surgery
Intravenous patient-controlled analgesia Patient-controlled epidural analgesia
| Study group | Role | What they receive |
|---|---|---|
| A (IV-PCA group) | Experimental | IV-PCA drug: Fentanyl 3000 mcg and Oxycodone 100 mg were mixed Normal saline 200 ml Receives: Procedure: Patient-controlled analgesia |
| B (PCEA group) | Experimental | 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 Receives: Procedure: Patient-controlled analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 2 postoperatively
Secondary outcomes (1)
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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Jan 2018
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sang-Jae Park, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352023
- Sponsor's protocol ID
- NCC-2017-0274
- Status last verified
- Apr 2020
- First submitted
- 2 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficacy After Major Surgery in Pancreatobiliary Cancers: Intravenous Patient-controlled Analgesia Versus Patient-controlled Epidural Analgesia
- ClinicalTrials.gov ID
- NCT04352023
- Acronym / sponsor ID
- NCC-2017-0274
- Conditions
- Pancreatic Cancer, Biliary Tract Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| A (IV-PCA group) | Experimental | Procedure: Patient-controlled analgesiaIV-PCA drug: Fentanyl 3000 mcg and Oxycodone 100 mg were mixed Normal saline 200 ml |
| B (PCEA group) | Experimental | Procedure: Patient-controlled analgesiaPCEA 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 |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pancreatobiliary malignancies
- Anticipating open surgery
- Written concent
Key exclusion criteria (8 listed)
- History of previous upper abdominal open surgery
- Psychiatric problems
- Cognitive impairment
- Chronic pain
- Elimination Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-controlled analgesiaIntravenous patient-controlled analgesia Patient-controlled epidural analgesia | Procedure or surgery | A (IV-PCA group), B (PCEA group) |
Primary outcome
Comparison of analgesic efficacy after major surgery in pancreatobiliary cancers: Intravenous patient-controlled analgesia versus patient-controlled epidural analgesia
Time frame: Day 2 postoperatively
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
1 secondary outcome
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
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Pancreatic Cancer and Biliary Tract Neoplasms, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of analgesic efficacy after major surgery in pancreatobiliary cancers: Intravenous patient-controlled analgesia versus patient-controlled epidural analgesia (time frame: Day 2 postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.