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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019777
Receipt No. R000021083
Scientific Title Efficacy of programmed intermittent bolus compared to continuous infusion in combination with patient-controlled epidural analgesia for postoperative pain management after pylorus-preserving pancreaticoduodenectomy
Date of disclosure of the study information 2015/11/16
Last modified on 2015/12/05

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Basic information
Public title Efficacy of programmed intermittent bolus compared to continuous infusion in combination with patient-controlled epidural analgesia for postoperative pain management after pylorus-preserving pancreaticoduodenectomy
Acronym PIB in combination with PCEA
Scientific Title Efficacy of programmed intermittent bolus compared to continuous infusion in combination with patient-controlled epidural analgesia for postoperative pain management after pylorus-preserving pancreaticoduodenectomy
Scientific Title:Acronym PIB in combination with PCEA
Region
Japan

Condition
Condition Pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to determine whether programmed intermittent bolus (PIB) automatically provides better postoperative pain relief without increasing adverse effects after PPPD than that provided by CI as a background infusion technique of PCEA.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes 1) Pain intensity at rest and during movement at 0, 2, 4, , 8, 12 postoperatively
2) Dose of PCA bolus for 12 hours
3) Dose of supplemental analgesic for 12 hours
Key secondary outcomes 1) Hemodynamic data (heart rate, blood pressure)at 0, 2, 4, , 8, 12 postoperatively
2) Adverse effects for 12 hours
3) Patient's satisfaction at 12 hr postoperatively

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Patients were assigned as a delivery method to 2 groups.
Group P(programed intermittent bolus; 4 or 6 ml every 60 min, PCA bolus; 3 ml, lock out time; 30 min)

dose of intermittent bolus
HT < 155 cm; 4 ml
HT > 155 cm; 6 ml

HT: height
Interventions/Control_2 Group C (continuous infusion; 4 or 6 ml/h, PCA bolus; 3 ml, lock out time; 30 min)

rate of continuous dose
HT < 155 cm; 4 ml/h
HT > 155 cm; 6 ml/h

HT: height
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria American Society of Anesthesiologists physical status I or II

Patients were scheduled for elective pylorus-preserving pancreaticoduodenectomy (PPPD) under epidural block and general anesthesia
Key exclusion criteria Patients with respiratory disorder
Patients with heart failure
Patients with anticoagulant therapy
Patients with obesity(BMI > 35)
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukitoshi Niiyama
Organization Sapporo Medical University School of Medicine
Division name Department of Anesthesiology
Zip code
Address School of Medicine, South 1 West 16 Chuo-ku, Sapporo, Hokkaido, Japan
TEL 011-611-2111
Email niiyama@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukitoshi Niiyama
Organization Sapporo Medical University School of Medicine
Division name Department of Anesthesiology
Zip code
Address South 1 West 16 Chuo-ku, Sapporo, Hokkaido, 060-8556, Japan
TEL 011-611-2111
Homepage URL
Email niiyama@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization Smiths Medical, Japan
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2014 Year 01 Month 09 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 13 Day
Last modified on
2015 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021083

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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