Preperitoneal Analgesia Versus Epidural Analgesia After Open Pancreaticoduodenectomy

NCT ID: NCT04375826

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-13
• Study Completion Date: 2024-12-31

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.

Conditions

Pain Management; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Epidural analgesia

Only Epidural analgesia is used for this group

Group Type: ACTIVE_COMPARATOR

Epidural patient controlled analgesia

Intervention Type: DEVICE

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

This group is given with both preperitoneal analgesia and Intravenous Patient Controlled Analgesia (IV-PCA)

Group Type: ACTIVE_COMPARATOR

Preperitoneal analgesia and IV-PCA

Intervention Type: DEVICE

During surgery, the preperitoneal analgesia catheters are inserted into the preperitoneal space and these catheters are connected to the pump with ropivacaine.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin-Young Jang

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin-Young Jang, M.D., PhD.

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

Department of Surgery, Seoul National University College of Medicine

Seoul, , South Korea

Countries

South Korea

References

Lee M, Jung JY, Han Y, Chae YS, Yun WG, Jung HS, Cho YJ, Choi YJ, Lee HJ, Kwon W, Kim WH, Jang JY. Continuous preperitoneal versus thoracic epidural analgesia in open pancreatoduodenectomy: randomized clinical trial. Br J Surg. 2024 Nov 27;111(12):znae296. doi: 10.1093/bjs/znae296.

Reference Type: DERIVED

PMID: 39602790 (View on PubMed)

Other Identifiers

2003-128-111

Identifier Type: -

Identifier Source: org_study_id