Preperitoneal Analgesia Versus Epidural Analgesia After Open Pancreaticoduodenectomy (Pain)

Seoul National University

Status: Active, not recruiting

Conditions: Pain Management; Pain, Postoperative

Treatments: Device: Preperitoneal analgesia and IV-PCA; Device: Epidural patient controlled analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04375826

2003-128-111

Details and patient eligibility

About

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

Full 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.

Enrollment: 146 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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146 participants in 2 patient groups

Epidural analgesia

Active Comparator group

Description:

Only Epidural analgesia is used for this group

Treatment:

Device: Epidural patient controlled analgesia

Preperitoneal analgesia and IV-PCA

Active Comparator group

Description:

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

Treatment:

Device: Preperitoneal analgesia and IV-PCA