UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019777 |
|---|---|
| Receipt number | 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 07:43:44 |
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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
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
niiyama@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021083
