Pain ManagementPainNCT04375826
Preperitoneal Analgesia Versus Epidural Analgesia After Open Pancreaticoduodenectomy
A study testing Preperitoneal analgesia and IV-PCA in people with Pain Management and Pain, Postoperative, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This is a prospective randomized open-label noninferiority trial that compares thoracic epidural analgesia and continuous preperitoneal analgesia after open pancreaticoduodenectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management, Pain, Postoperative
- What is being tested?
- Preperitoneal analgesia and IV-PCA
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Nov 2020to 31 Dec 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- Disease of periampullary lesions
- Elective open pancreaticoduodenectomy (PD): PD or pylorus preserving pancreaticoduodenectomy (PPPD)
- Midline incision
- Written informed consent : ability to understand and the willingness to sign a written informed consent
- Performance status (ECOG scale): 0-1 at the time of enrollment
- Physical status (ASA) : 1-2 grade
Who cannot join
- History of any abdominal surgery (except laparoscopic appendectomy, laparoscopic/robotic cholecystectomy, laparoscopic/robotic obstetrics and gynecology surgeries,Cesarean section, laparoscopic/robotic prostate surgery)
- Emergency operation
- History of chronic pain
- Chronic use of opioid, analgesics, anti-depressant, anti-epileptics (>1year)
- Alcoholics
- Impossible to control PCA d/t delirium, cognitive impairment
Show all 11Show fewer
- Contraindication for epidural analgesia
- Patients with coagulopathy (INR>1.5, Prothrombin time>1.5, platelets <80x10^9perL) or anti-coagulants
- Hypersensitive to fentanyl and ropivacaine
- Need other organ resection (ex. Liver, colon)
- Intubation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Surgery, Seoul National University College of Medicine
Seoul, 110-744
About this study
Official title: Continuous Preperitoneal Analgesia Versus Thoracic Epidural Analgesia After Open Pancreaticoduodenectomy: a Randomized Controlled Open-labeled Noninferiority Trial
This is a prospective randomized open-label noninferiority trial that compares thoracic epidural analgesia and continuous preperitoneal analgesia after open pancreaticoduodenectomy.
Read the detailed description
In the Enhanced recovery after surgery (ERAS) program of pancreaticoduodenectomy (PD), thoracic epidural analgesia (or epidural analgesia) was considered to be a key analgesic method because it not only effectively controls pain, but also lowers insulin resistance and helps restore bowel movement. However, epidural analgesia can cause a number of side effects despite of effective pain control. Epidural analgesia reduces peripheral vascular resistance by blocking sympathetic nerves with local anesthetics and may cause hypotension and decreasing heart rate. In addition, it can cause orthostatic hypotension, which can interfere with early ambulation after operation. In rare cases, there are potential complications of epidural abscess, meningitis, and epidural hematoma.
Continuous peritoneal analgesia using local anesthetics has recently been used as an alternative analgesic to epidural analgesia in open abdomen surgery. This is easier to perform than epidural analgesia and is known to have fewer side effects. Recently, a non-inferiority comparison study have revealed that peritoneal analgesic was not inferior to epidural analgesia in terms of pain control. However, this study included a variety of operations other than PD, and most of the incisions were substernal, not midline. In addition, the method for mounting the epidural catheter was not described. The failure rate of the epidural catheter was reported to be 15%.
The investigators will examine the effect of continuous peritoneal analgesic postoperative pain control in patients undergoing open PD to improve postoperative pain management and to create an our own ERAS program. To this end, The investigators will test non-inferiority between epidural analgesia and peritoneal analgesia.
- Conditions
- Pain Management, Pain, Postoperative
- Being tested
- Epidural patient controlled analgesia, Preperitoneal analgesia and IV-PCA
- Keywords
- Pain management, Postoperative pain
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural patient controlled analgesiaDevice
The device is connected to the epidural catheter prior to surgery and drug administration is started during surgery. The continuous infusion rate is 4 ml / hr. When the button is pressed, 2 ml is additionally administered and the lock time is 20 minutes.
Preperitoneal analgesia and IV-PCADevice
During surgery, the preperitoneal analgesia catheters are inserted into the preperitoneal space and these catheters are connected to the pump with ropivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Epidural analgesia | Active comparator | Only Epidural analgesia is used for this group Receives: Device: Epidural patient controlled analgesia |
| Preperitoneal analgesia and IV-PCA | Active comparator | This group is given with both preperitoneal analgesia and Intravenous Patient Controlled Analgesia (IV-PCA) Receives: Device: Preperitoneal analgesia and IV-PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean numerical rating score for pain after operation
The scale of the numerical rating score for pain is 0~10 and higher score is worse outcome.
Mean NRS pain scores are compared between two groups.
Measured: 1-3 days after operation
Secondary outcomes (7)
Pain related factors
The scale of the numerical rating score for pain is 0~10 and higher score is worse outcome.
Numerical rating score for pain on postoperative day 1, 2 and 3 at 4pm
Measured: postoperative day 1,2,and 3
QoR-15 Survey
QoR-15 survey on postoperative day 1,2,and 3.
Measured: postoperative day 1,2,and 3
Recovery related factors
Time to first eat meal, time to first move, time to first gas out
Measured: Within 1 week after operation
Postoperative complication factors
Clavien-Dindo classification, postoperative pancreatic fistula
Measured: Within 1 week after operation
analgesic related factors
rescue analgesics amounts, opioid amounts
Measured: postoperative day 1,2,and 3
Opioid related factors
nausea, hypotension, respiratory depression
Measured: postoperative day 1,2,and 3
Hospital stay
postoperative hospital stay day
Measured: at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start13 Nov 2020
- Primary completion26 Oct 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Jang, Seoul National University Hospital
- Investigators
- Jin-Young Jang, M.D., PhD., Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375826
- Sponsor's protocol ID
- 2003-128-111
- Acronym
- Pain
- Status last verified
- Oct 2024
- First submitted
- 26 Apr 2020
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee M, Jung JY, Han Y, Chae YS, Yun WG, Jung HS, Cho YJ, Choi YJ, Lee HJ, Kwon W, Kim WH, Jang JY. Continuous preperitoneal versus thoracic epidural analgesia in open pancreatoduodenectomy: randomized clinical trial. Br J Surg. 2024 Nov 27;111(12):znae296. doi: 10.1093/bjs/znae296.
PubMed 39602790
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Preperitoneal Analgesia Versus Thoracic Epidural Analgesia After Open Pancreaticoduodenectomy: a Randomized Controlled Open-labeled Noninferiority Trial
- ClinicalTrials.gov ID
- NCT04375826
- Acronym / sponsor ID
- Pain / 2003-128-111
- Conditions
- Pain Management, Pain, Postoperative
- Keywords
- Pain management, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 May 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.
This is a prospective randomized open-label noninferiority trial that compares thoracic epidural analgesia and continuous preperitoneal analgesia after open pancreaticoduodenectomy.
Detailed description
In the Enhanced recovery after surgery (ERAS) program of pancreaticoduodenectomy (PD), thoracic epidural analgesia (or epidural analgesia) was considered to be a key analgesic method because it not only effectively controls pain, but also lowers insulin resistance and helps restore bowel movement. However, epidural analgesia can cause a number of side effects despite of effective pain control. Epidural analgesia reduces peripheral vascular resistance by blocking sympathetic nerves with local anesthetics and may cause hypotension and decreasing heart rate. In addition, it can cause orthostatic hypotension, which can interfere with early ambulation after operation. In rare cases, there are potential complications of epidural abscess, meningitis, and epidural hematoma.
Continuous peritoneal analgesia using local anesthetics has recently been used as an alternative analgesic to epidural analgesia in open abdomen surgery. This is easier to perform than epidural analgesia and is known to have fewer side effects. Recently, a non-inferiority comparison study have revealed that peritoneal analgesic was not inferior to epidural analgesia in terms of pain control. However, this study included a variety of operations other than PD, and most of the incisions were substernal, not midline. In addition, the method for mounting the epidural catheter was not described. The failure rate of the epidural catheter was reported to be 15%.
The investigators will examine the effect of continuous peritoneal analgesic postoperative pain control in patients undergoing open PD to improve postoperative pain management and to create an our own ERAS program. To this end, The investigators will test non-inferiority between epidural analgesia and peritoneal analgesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural analgesia | Active comparator | Device: Epidural patient controlled analgesiaOnly Epidural analgesia is used for this group |
| Preperitoneal analgesia and IV-PCA | Active comparator | Device: Preperitoneal analgesia and IV-PCAThis group is given with both preperitoneal analgesia and Intravenous Patient Controlled Analgesia (IV-PCA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years and older
- Disease of periampullary lesions
- Elective open pancreaticoduodenectomy (PD): PD or pylorus preserving pancreaticoduodenectomy (PPPD)
- Midline incision
- Written informed consent : ability to understand and the willingness to sign a written informed consent
Key exclusion criteria (11 listed)
- History of any abdominal surgery (except laparoscopic appendectomy, laparoscopic/robotic cholecystectomy, laparoscopic/robotic obstetrics and gynecology surgeries,Cesarean section, laparoscopic/robotic prostate surgery)
- Emergency operation
- History of chronic pain
- Chronic use of opioid, analgesics, anti-depressant, anti-epileptics (>1year)
- Alcoholics
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 |
|---|---|---|
| Epidural patient controlled analgesiaThe device is connected to the epidural catheter prior to surgery and drug administration is started during surgery. The continuous infusion rate is 4 ml / hr. When the button is pressed, 2 ml is additionally administered and the lock time is 20 minutes. | Device | Epidural analgesia |
| Preperitoneal analgesia and IV-PCADuring surgery, the preperitoneal analgesia catheters are inserted into the preperitoneal space and these catheters are connected to the pump with ropivacaine. | Device | Preperitoneal analgesia and IV-PCA |
Primary outcome
Mean numerical rating score for pain after operation
Time frame: 1-3 days after operation
The scale of the numerical rating score for pain is 0~10 and higher score is worse outcome. Mean NRS pain scores are compared between two groups.
7 secondary outcomes
Pain related factors
Time frame: postoperative day 1,2,and 3
QoR-15 Survey
Time frame: postoperative day 1,2,and 3
Recovery related factors
Time frame: Within 1 week after operation
Postoperative complication factors
Time frame: Within 1 week after operation
analgesic related factors
Time frame: postoperative day 1,2,and 3
Opioid related factors
Time frame: postoperative day 1,2,and 3
Hospital stay
Time frame: at discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 39602790Lee M, Jung JY, Han Y, Chae YS, Yun WG, Jung HS, Cho YJ, Choi YJ, Lee HJ, Kwon W, Kim WH, Jang JY. Continuous preperitoneal versus thoracic epidural analgesia in open pancreatoduodenectomy: randomized clinical trial. Br J Surg. 2024 Nov 27;111(12):znae296. doi: 10.1093/bjs/znae296.
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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.
Jin-Young Jang, M.D., PhD. study chair
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preperitoneal analgesia and IV-PCA in people with Pain Management and Pain, Postoperative, run by Seoul National University Hospital 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 7 inclusion and 11 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 15 Oct 2024. 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.
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?
Mean numerical rating score for pain after operation (time frame: 1-3 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04375826, which also lists 1 linked publication.
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 15 Oct 2024.