Preperitoneal Analgesia Versus Epidural Analgesia After Open Pancreaticoduodenectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Continuous Preperitoneal Analgesia Versus Thoracic Epidural Analgesia After Open Pancreaticoduodenectomy: A Randomized Controlled Open-labeled Noninferiority Trial

Conditions
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Pain Management, Pain, Postoperative

Intervention / Treatment
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* Device: Epidural patient controlled analgesia
* Device: Preperitoneal analgesia and IV-PCA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural analgesia<br>Only Epidural analgesia is used for this group | Device: Epidural patient controlled analgesia<br>* 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.<br>|
| Active Comparator: Preperitoneal analgesia and IV-PCA<br>This group is given with both preperitoneal analgesia and Intravenous Patient Controlled Analgesia (IV-PCA) | Device: Preperitoneal analgesia and IV-PCA<br>* During surgery, the preperitoneal analgesia catheters are inserted into the preperitoneal space and these catheters are connected to the pump with ropivacaine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical rating score for pain at 24 hours after operation | The scale of the numerical rating score for pain is 0 10 and higher score is worse outcome. At 24 hours after operation, NRS pain scores are compared between two groups. | 24 hours after operation | 

Secondary Outcome Measures

| Outcome Measure | 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 2 and 3 at 4pm | postoperative day 1,2,and 3 | 
| Overall benefit of analgesia score (OBAS) | OBAS on postoperative day 1,2,and 3. This include 7 questions. To calculate the OBAS score, compute the sume of scores in items 1 6 and add 4-socore in item 7. The minimum score is 4 and the maximum is 24.The low score indicates high benefit. | 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 | Within 2 week after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain management, Postoperative pain