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NCT Number: NCT04375826

Preperitoneal Analgesia Versus Epidural Analgesia After Open Pancreaticoduodenectomy

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

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Seoul National University College of Medicine

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epidural patient controlled analgesia

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

Device

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

Primary outcomes

  1. Mean numerical rating score for pain after operation

    Time frame: 1-3 days after operation

    The scale of the numerical rating score for pain is 0~10 and higher score is worse outcome.

    Mean NRS pain scores are compared between two groups.

Secondary outcomes

  1. Pain related factors

    Time frame: postoperative day 1,2,and 3

    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 1, 2 and 3 at 4pm

  2. QoR-15 Survey

    Time frame: postoperative day 1,2,and 3

    QoR-15 survey on postoperative day 1,2,and 3.

  3. Recovery related factors

    Time frame: Within 1 week after operation

    Time to first eat meal, time to first move, time to first gas out

  4. Postoperative complication factors

    Time frame: Within 1 week after operation

    Clavien-Dindo classification, postoperative pancreatic fistula

  5. analgesic related factors

    Time frame: postoperative day 1,2,and 3

    rescue analgesics amounts, opioid amounts

  6. Opioid related factors

    Time frame: postoperative day 1,2,and 3

    nausea, hypotension, respiratory depression

  7. Hospital stay

    Time frame: at discharge

    postoperative hospital stay day

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: Pain

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
May 5, 2020
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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