Department of Surgery, Seoul National University College of Medicine
Seoul, 110-744, South Korea
NCT Number: NCT04375826
This is a prospective randomized open-label noninferiority trial that compares thoracic epidural analgesia and continuous preperitoneal analgesia after open pancreaticoduodenectomy.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Seoul, 110-744, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
During surgery, the preperitoneal analgesia catheters are inserted into the preperitoneal space and these catheters are connected to the pump with ropivacaine.
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.
Time frame: 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
Time frame: postoperative day 1,2,and 3
QoR-15 survey on postoperative day 1,2,and 3.
Time frame: Within 1 week after operation
Time to first eat meal, time to first move, time to first gas out
Time frame: Within 1 week after operation
Clavien-Dindo classification, postoperative pancreatic fistula
Time frame: postoperative day 1,2,and 3
rescue analgesics amounts, opioid amounts
Time frame: postoperative day 1,2,and 3
nausea, hypotension, respiratory depression
Time frame: at discharge
postoperative hospital stay day
Seoul National University Hospital
Other
Continuous Preperitoneal Analgesia Versus Thoracic Epidural Analgesia After Open Pancreaticoduodenectomy: a Randomized Controlled Open-labeled Noninferiority Trial
Acronym: Pain
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