Preperitoneal Analgesia Versus Epidural Analgesia After Open Pancreaticoduodenectomy (Pain)

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

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

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Pain Management
• Intervention / Treatment: Device: Epidural patient controlled analgesia; Device: Preperitoneal analgesia and IV-PCA

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.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jin-Young Jang, M.D., PhD.; Phone Number: 82-2-2072-2194; Email: jangjy4@snu.ac.kr
• Study Contact Backup: Name: Yoo Jin Choi, M.D.; Phone Number: 82-2-2072-1959; Email: ujinny30@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Recruiting
    • Department of Surgery, Seoul National University College of Medicine
    • Contact: Jin- Young Jang, M.D., PhD.; Phone Number: 82-2-2072-2194; Email: jangjy4@gmail.com
    • Contact: Wooil Kwon, M.D., PhD.; Phone Number: 82-2-2072-2817; Email: willdoc78@gmail.com
    • Principal Investigator: Jin- Young Jang, M.D., PhD.
    • Sub-Investigator: Wooil Kwon, M.D., PhD.
    • Sub-Investigator: Hongbeom Kim, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Epidural analgesia; Only Epidural analgesia is used for this group	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.
Active Comparator: Preperitoneal analgesia and IV-PCA; This group is given with both preperitoneal analgesia and Intravenous Patient Controlled Analgesia (IV-PCA)	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Chair: Jin-Young Jang, M.D., PhD., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 26, 2020
• First Submitted That Met QC Criteria: May 2, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Pain management; Postoperative pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2003-128-111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No