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

National Cancer Center (NCC)

Status and phase: Unknown; Phase 2

Conditions: Biliary Tract Neoplasms; Pancreatic Cancer

Treatments: Procedure: Patient-controlled analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04352023

NCC-2017-0274

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

110 participants in 2 patient groups

A (IV-PCA group)

Experimental group

Description:

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

Treatment:

Procedure: Patient-controlled analgesia

B (PCEA group)

Experimental group

Description:

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

Treatment:

Procedure: Patient-controlled analgesia