Analgesic Efficacy After Pancreatobiliary Surgery: Intravenous Versus Patient-controlled Epidural

NCT04352023 | Unknown Phase 2

• 1 other identifier: NCC-2017-0274
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, single institute based, open label, double arm, randomized controlled trial Hypothesis: Pain control after resection of hepatobiliary tumors in patients with PCEA is more effective than in patients with IV-PCA.

Conditions

Pancreatic Cancer; Biliary Tract Neoplasms

Outcome Measures

Primary Outcomes (1)

• Comparison of analgesic efficacy after major surgery in pancreatobiliary cancers: Intravenous patient-controlled analgesia versus patient-controlled epidural analgesia

  Comparison of pain scale (Numeric rating scale; minimum: 0, maximum: 10) of IV PCA and PCEA during ambulation on the day 2 postoperatively; Scale 0 means no pain and scale 10 means most painful

  Day 2 postoperatively

Secondary Outcomes (1)

• Investigation and comparison of pain and clinical progress during rest after surgery, side effects of drugs administered to IV-PCA and PCEA, and complications related to PCEA procedure

  7 days

Study Arms (2)

A (IV-PCA group)

EXPERIMENTAL

IV-PCA drug: Fentanyl 3000 mcg and Oxycodone 100 mg were mixed Normal saline 200 ml

Procedure: Patient-controlled analgesia

B (PCEA group)

EXPERIMENTAL

PCEA drug: Morphine 5 mg and Ropivacaine 750 mg were mixed Normal saline 400 ml loading of preadministered Morphine 1 mg and Ropivacaine 11.25 mg

Procedure: Patient-controlled analgesia

Interventions

Patient-controlled analgesia PROCEDURE

Intravenous patient-controlled analgesia Patient-controlled epidural analgesia

A (IV-PCA group); B (PCEA group)

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pancreatobiliary malignancies
• Anticipating open surgery
• Written concent

You may not qualify if:

• History of previous upper abdominal open surgery
• Psychiatric problems
• Cognitive impairment
• Chronic pain
• Elimination Criteria
• Rejected written concent
• Failure to follow instructions of doctor
• Stopped surgery due to peritoneal metastasis

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Biliary Tract Neoplasms

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Diseases

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 2, 4, 6 block randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Model Details: Randomized controlled trial, prospective, single institute Experimental: A IV-PCA group IV-PCA drug: Fentanyl 3000 mcg and Oxycodone 100 mg were mixed Normal saline 200 ml Procedure/Surgery: Patient-controlled analgesia Intravenous patient-controlled analgesia Patient-controlled epidural analgesia Experimental: B PCEA group PCEA drug: Morphine 5 mg and Ropivacaine 750 mg were mixed Normal saline 400 ml loading of preadministered Morphine 1 mg and Ropivacaine 11.25 mg Procedure/Surgery: Patient-controlled analgesia Intravenous patient-controlled analgesia Patient-controlled epidural analgesia

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 17, 2020
• Study Start: January 1, 2018
• Primary Completion: April 30, 2020
• Study Completion: June 30, 2020
• Last Updated: April 17, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 years from the study completion date

Locations

KR (1)