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This is a prospective randomized open-label noninferiority trial that compares thoracic epidural analgesia and continuous preperitoneal analgesia after open pancreaticoduodenectomy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural analgesia | Active Comparator | Only Epidural analgesia is used for this group |
|
| Preperitoneal analgesia and IV-PCA | Active Comparator | This group is given with both preperitoneal analgesia and Intravenous Patient Controlled Analgesia (IV-PCA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural patient controlled analgesia | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-3 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | postoperative day 1,2,and 3 |
| QoR-15 Survey |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Young Jang, M.D., PhD. | Seoul National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Seoul National University College of Medicine | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39602790 | Derived | 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. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D016058 | Analgesia, Patient-Controlled |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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|
| Preperitoneal analgesia and IV-PCA | Device | During surgery, the preperitoneal analgesia catheters are inserted into the preperitoneal space and these catheters are connected to the pump with ropivacaine. |
|
QoR-15 survey on postoperative day 1,2,and 3.
| postoperative day 1,2,and 3 |
| Recovery related factors | Time to first eat meal, time to first move, time to first gas out | Within 1 week after operation |
| Postoperative complication factors | Clavien-Dindo classification, postoperative pancreatic fistula | Within 1 week after operation |
| analgesic related factors | rescue analgesics amounts, opioid amounts | postoperative day 1,2,and 3 |
| Opioid related factors | nausea, hypotension, respiratory depression | postoperative day 1,2,and 3 |
| Hospital stay | postoperative hospital stay day | at discharge |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |