Preperitoneal Analgesia Versus Epidural Analgesia After Open Pancreaticoduodenectomy

Pain, Postoperative Clinical Trial

— Pain  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04375826
• Other study ID #: 2003-128-111
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Seoul National University Hospital
• Contact: Jin-Young Jang, M.D., PhD.
• Phone: 82-2-2072-2194
• Email: jangjy4[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective randomized open-label noninferiority trial that compares thoracic epidural analgesia and continuous preperitoneal analgesia after open pancreaticoduodenectomy.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain Management
• Pain, Postoperative

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Surgery, Seoul National University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Recovery related factors	Time to first eat meal, time to first move, time to first gas out	Within 1 week after operation
Secondary	Postoperative complication factors	Clavien-Dindo classification, postoperative pancreatic fistula	Within 1 week after operation
Secondary	analgesic related factors	rescue analgesics amounts, opioid amounts	Within 2 week after operation