NCT04375826

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

November 13, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

3 years

First QC Date

April 26, 2020

Last Update Submit

October 10, 2024

Conditions

Pain ManagementPain, Postoperative

Keywords

Pain managementPostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Mean numerical rating score for pain 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.

    1-3 days after operation

Secondary Outcomes (7)

  • Pain related factors

    postoperative day 1,2,and 3

  • QoR-15 Survey

    postoperative day 1,2,and 3

  • Recovery related factors

    Within 1 week after operation

  • Postoperative complication factors

    Within 1 week after operation

  • analgesic related factors

    postoperative day 1,2,and 3

  • +2 more secondary outcomes

Study Arms (2)

Epidural analgesia

ACTIVE COMPARATOR

Only Epidural analgesia is used for this group

Device: Epidural patient controlled analgesia

Preperitoneal analgesia and IV-PCA

ACTIVE COMPARATOR

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

Device: Preperitoneal analgesia and IV-PCA

Interventions

Epidural patient controlled analgesiaDEVICE

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.

Epidural analgesia
Preperitoneal analgesia and IV-PCADEVICE

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

Preperitoneal analgesia and IV-PCA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Seoul National University College of Medicine

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 39602790DERIVED

MeSH Terms

Conditions

AgnosiaPain, Postoperative

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPain

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Officials

  • Jin-Young Jang, M.D., PhD.

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 26, 2020

First Posted

May 5, 2020

Study Start

November 13, 2020

Primary Completion

October 26, 2023

Study Completion

December 31, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Locations

KR(1)