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

NCT ID: NCT04352023

Last Updated: 2020-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-06-30

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.

Detailed Description

Postoperative pain control is important in helping patients who underwent abdominal surgery to recover and to live a normal life. There is a method of administering painless injections to relieve postoperative pain. Currently, IV-PCA is mostly used. However, this method has a disadvantage in that the dosage of the opioid-based analgesic is increased, and thus side effects may be concerned. By administering analgesics through an epidural route approached through the thoracic vertebrae rather than intravenous injection, effective post-operative pain control and less side effects can be expected in lesser amounts. This study prospectively compared the pain control effects of IV-PCA and PCEA in patients undergoing resection of hepatobiliary tumors at the National Cancer Center, revealing that PCEA is more effective in alleviating pain after surgery. It has a purpose. In addition, the investigators will investigate and compare clinical outcomes (first fart, dietary progression, postoperative complications, etc.) of the two patient groups and investigate the side effects of PCEA and complications related to the procedure.

Conditions

Pancreatic Cancer; Biliary Tract Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

A (IV-PCA group)

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

Group Type: EXPERIMENTAL

Patient-controlled analgesia

Intervention Type: PROCEDURE

Intravenous patient-controlled analgesia Patient-controlled epidural analgesia

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

Group Type: EXPERIMENTAL

Patient-controlled analgesia

Intervention Type: PROCEDURE

Intravenous patient-controlled analgesia Patient-controlled epidural analgesia

Interventions

Patient-controlled analgesia

Intravenous patient-controlled analgesia Patient-controlled epidural analgesia

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Pancreatobiliary malignancies
• Anticipating open surgery
• Written concent

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sang-Jae Park

Research Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

NCC-2017-0274

Identifier Type: -

Identifier Source: org_study_id