NCT04352023

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

Comparison of Analgesic Efficacy After Major Surgery in Pancreatobiliary Cancers: Intravenous Patient-controlled Analgesia Versus Patient-controlled Epidural Analgesia

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Patient-controlled analgesia	Intravenous patient-controlled analgesia Patient-controlled epidural analgesia

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-04-30
• Completion: 2020-06-30
• First posted: 2020-04-17
• Last updated: 2020-04-17

Locations

1 site across 1 country: South Korea