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

Phase 2

• Conditions: Pancreatic Cancer; Biliary Tract Neoplasms
• Interventions: Procedure: Patient-controlled analgesia

• Registration Number: NCT04352023
• Lead Sponsor: National Cancer Center, Korea

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.

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-02
• Study First Submitted QC: 2020-04-15
• Last Update Submitted: 2020-04-15
• Study First Posted: 2020-04-17
• Last Update Posted: 2020-04-17
• Primary Completion: 2020-04-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A (IV-PCA group)	Patient-controlled analgesia	IV-PCA drug: Fentanyl 3000 mcg and Oxycodone 100 mg were mixed Normal saline 200 ml
B (PCEA group)	Patient-controlled analgesia	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

Primary Outcome Measures

Name	Time	Method
Comparison of analgesic efficacy after major surgery in pancreatobiliary cancers: Intravenous patient-controlled analgesia versus patient-controlled epidural analgesia	Day 2 postoperatively	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

Secondary Outcome Measures

Name	Time	Method
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	Comparison of pain scale (Numeric rating scale; minimum: 0, maximum: 10) of IV PCA and PCEA during rest from the day 1 to 7 postoperatively; comparison of amount of totally infused analgesics, serum level of troponin I on the day 1 postoperatively, and incidence of postoperative complications between the two groups; investigation of PCEA-related complications and adverse effects of analgesics

Trial Locations

Locations (1)

National Cancer Center; 🇰🇷 Goyang, Gyeonggi, Korea, Republic of