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

Sponsor

National Cancer Center, Korea (Other)

Overall Status

Unknown status

CT.gov ID

NCT04352023

Collaborator

(none)

110

Enrollment

Locations

Arms

29.9

Anticipated Duration (Months)

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Biliary Tract Neoplasms	Procedure: Patient-controlled analgesia	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 analgesiaRandomized 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

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

2, 4, 6 block randomization

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Anticipated Primary Completion Date :

Apr 30, 2020

Anticipated Study Completion Date :

Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A (IV-PCA group) IV-PCA drug: Fentanyl 3000 mcg and Oxycodone 100 mg were mixed Normal saline 200 ml	Procedure: 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: Patient-controlled analgesia Intravenous patient-controlled analgesia Patient-controlled epidural analgesia

Arm

Intervention/Treatment

Experimental: A (IV-PCA group)

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

Procedure: 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: Patient-controlled analgesia

Intravenous patient-controlled analgesia Patient-controlled epidural analgesia

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Center	Goyang-si	Gyeonggi-do	Korea, Republic of	410-769
2	National Cancer Center	Goyang	Gyeonggi	Korea, Republic of	410-769

Sponsors and Collaborators

National Cancer Center, Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sang-Jae Park, Research Director, National Cancer Center, Korea

ClinicalTrials.gov Identifier:

NCT04352023

Other Study ID Numbers:

NCC-2017-0274

First Posted:

Apr 17, 2020

Last Update Posted:

Apr 17, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Biliary Tract Neoplasms

Study Results

No Results Posted as of Apr 17, 2020