Pain Management, Pain, Postoperative
Conditions
Keywords
Pain management, Postoperative pain
Brief summary
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.
Interventions
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.
DEVICEPreperitoneal analgesia and IV-PCA
During surgery, the preperitoneal analgesia catheters are inserted into the preperitoneal space and these catheters are connected to the pump with ropivacaine.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean numerical rating score for pain after operation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QoR-15 Survey | postoperative day 1,2,and 3 | QoR-15 survey on postoperative day 1,2,and 3. |
| Recovery related factors | Within 1 week after operation | Time to first eat meal, time to first move, time to first gas out |
| Postoperative complication factors | Within 1 week after operation | Clavien-Dindo classification, postoperative pancreatic fistula |
| Pain related factors | postoperative day 1,2,and 3 | 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 |
| Opioid related factors | postoperative day 1,2,and 3 | nausea, hypotension, respiratory depression |
| Hospital stay | at discharge | postoperative hospital stay day |
| analgesic related factors | postoperative day 1,2,and 3 | rescue analgesics amounts, opioid amounts |
Countries
South Korea
Outcome results
None listed