UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020294 |
|---|---|
| Receipt number | R000023435 |
| Scientific Title | A comparative study of analgesic effects between continuous epidural infusion (CEI) and programmed intermittent epidural bolus (PIEB) after video-assisted thoracoscopic surgery for lung tumors. |
| Date of disclosure of the study information | 2015/12/21 |
| Last modified on | 2017/06/22 16:42:32 |
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Basic information
Public title
A comparative study of analgesic effects between continuous epidural infusion (CEI) and programmed intermittent epidural bolus (PIEB) after video-assisted thoracoscopic surgery for lung tumors.
Acronym
Comparison of CEI and PIEB after video-assisted thoracoscopic surgery.
Scientific Title
A comparative study of analgesic effects between continuous epidural infusion (CEI) and programmed intermittent epidural bolus (PIEB) after video-assisted thoracoscopic surgery for lung tumors.
Scientific Title:Acronym
Comparison of CEI and PIEB after video-assisted thoracoscopic surgery.
Region
| Japan |
Condition
Condition
Lung tumors
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of postoperative epidural analgesia between continuous epidural infusion and programmed intermittent epidural bolus delivered by the Computerized Ambulatory Drug Delivery pump (CADD pump).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numerical Rating Scale of postoperative pain at rest and with coughing shortly, 1, 2, and 4 hours after admission to the ICU,
Key secondary outcomes
1) Extent of cold and pain sensory blockade on the first postoperative day.
2) Patient satisfaction
3) Occurrence of complications such as hypotension, bradycardia, hypopnea, nausea, and vomiting.
4) Frequency of patient controlled analgesia (PCA).
5) Total amount of rescue analgesic medication.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Continuous epidural infusion with ropivacaine 0.15% plus fentanyl 2.5 microgram/ml at a dose of 4 ml/h to patients till next morning after video-assisted thoracoscopic surgery for lung tumors.
Interventions/Control_2
Programmed intermittent epidural bolus delivered by the CADD pump with ropivacaine 0.15% plus fentanyl 2.5 microgram/ml at a dose of 3 ml every 45 minutes for a period of one minute to patients till next morning after video-assisted thoracoscopic surgery for lung tumors.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing video-assisted thoracoscopic surgery under general and epidural anesthesia, who are scheduled to be admitted to the ICU after surgery.
Key exclusion criteria
1) An American Society of Anesthesiologists Physical status of more than 3.
2) A patient who has a history of allergies or intolerance to local anesthetics or fentanyl.
3) A patient undergoing surgery without epidural anesthesia.
4) A patient undergoing another surgical procedure in combination with video-assisted thoracoscopic surgery.
5) A patient of less than height 150cm.
6) A patient who does not agree to participate this study.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Arisa Hotta |
Organization
Sumitomo Hospital
Division name
Department of Anesthesiology
Zip code
Address
5-3-20 Nakanoshima, Kita-ku, Osaka city, Osaka
TEL
81-6-6443-1261
hotta-arisa@sumitomo-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Arisa Hotta |
Organization
Sumitomo Hospital
Division name
Department of Anesthesiology
Zip code
Address
5-3-20 Nakanoshima, Kita-ku, Osaka city, Osaka
TEL
81-6-6443-1261
Homepage URL
hotta-arisa@sumitomo-hp.or.jp
Sponsor or person
Institute
Sumitomo Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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 | 12 | Month | 21 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 21 | 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 | 12 | Month | 21 | Day |
Last modified on
| 2017 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023435
