Clinical trial NCT04375826: Preperitoneal Analgesia Versus Epidural Analgesia After Open Pancreaticoduodenectomy
Official title: Continuous Preperitoneal Analgesia Versus Thoracic Epidural Analgesia After Open Pancreaticoduodenectomy: a Randomized Controlled Open-labeled Noninferiority Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pain Management
Pain, Postoperative
Keywords: Pain management
Postoperative pain
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Mean numerical rating score for pain after operation
timeFrame: 1-3 days after operation
Secondary outcomes:
measure: Pain related factors
timeFrame: postoperative day 1,2,and 3
measure: QoR-15 Survey
timeFrame: postoperative day 1,2,and 3
measure: Recovery related factors
timeFrame: Within 1 week after operation
measure: Postoperative complication factors
timeFrame: Within 1 week after operation
measure: analgesic related factors
timeFrame: postoperative day 1,2,and 3
measure: Opioid related factors
timeFrame: postoperative day 1,2,and 3
measure: Hospital stay
timeFrame: at discharge
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Seoul National University College of Medicine
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Young Jang, M.D., PhD.
role: STUDY_CHAIR
References: