NCT04375826

Preperitoneal Analgesia Versus Epidural Analgesia After Open Pancreaticoduodenectomy

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain Management
• Pain, Postoperative

Interventions

Type	Name	Description
DEVICE	Epidural patient controlled analgesia	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.
DEVICE	Preperitoneal 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.

Timeline

• Start date: 2020-11-13
• Primary completion: 2023-10-26
• Completion: 2024-12-31
• First posted: 2020-05-05
• Last updated: 2024-10-15

Locations

1 site across 1 country: South Korea