UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022372 |
|---|---|
| Receipt number | R000025382 |
| Scientific Title | Estimation of the Region Blocked by Epidural Anesthesia based on Skin Temperature Change, and Research on Improving Postoperative Analgesia |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2023/11/06 10:59:56 |
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Basic information
Public title
Estimation of the Region Blocked by Epidural Anesthesia based on Skin Temperature Change, and Research on Improving Postoperative Analgesia
Acronym
Estimation of the Region Blocked by Epidural Anesthesia based on Skin Temperature Change, and Research on Improving Postoperative Analgesia
Scientific Title
Estimation of the Region Blocked by Epidural Anesthesia based on Skin Temperature Change, and Research on Improving Postoperative Analgesia
Scientific Title:Acronym
Estimation of the Region Blocked by Epidural Anesthesia based on Skin Temperature Change, and Research on Improving Postoperative Analgesia
Region
| Japan |
Condition
Condition
Patients who are scheduled to undergo combined general and epidural anesthesia at our hospital.
Classification by specialty
| Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Continuous epidural anesthesia with local anesthetics is useful as a postoperative analgesic. However, its effect decreases if the anesthetic area is not sufficiently large; on the other hand, if the anesthetic area is too large, adverse reactions such as a decrease in blood pressure may occur because of sympathetic ganglion block. Ideally, an anesthetic area should spread from the wound site to an adequately large area in a seamless manner, starting from the perioperative phase to the postoperative phase. However, a detailed patient interview for evaluating skin sensation cannot be conducted immediately after general anesthesia. Thus, in this study, a thermographic camera will be used to indirectly evaluate the analgesic area of continuous epidural anesthesia; the usefulness of this method for postoperative analgesia will also be assessed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
An epidural anesthetic will be continuously administered starting 30-60 minutes before the completion of surgery. After the patient awakens from the general anesthesia, a thermographic camera will be used to determine how many segments the wound site is apart from the site of the sympathetic ganglion block. Although it is an unlikely event, if the analgesic effect is assessed to be inadequate (less than 2 segments), 3 ml of 0.2% ropivacaine will be added; on the other hand, if the effect is assessed to be excessive(>5 segments), the flow rate of continuous anesthesia will be decreased. The severity of postoperative pain will be assessed by ward nurses on a 4-point scale based on the amount of rescue analgesic administered to the patient.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
An epidural anesthetic will be continuously administered starting 30-60 minutes before the completion of surgery. After the patient awakens from the general anesthesia, a thermographic camera will be used to determine how many segments the wound site is apart from the site of the sympathetic ganglion block. Although it is an unlikely event, if the analgesic effect is assessed to be inadequate(less than 2 segments), 3 ml of 0.2% ropivacaine will be added; on the other hand, if the effect is assessed to be excessive(>5 segments), the flow rate of continuous anesthesia will be decreased.
Interventions/Control_2
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Among patients who are scheduled to undergo combined general and epidural anesthesia at our hospital, those who agree to participate in our study will be selected as study subjects.
Key exclusion criteria
None.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Taeko |
| Middle name | |
| Last name | Fukuda |
Organization
Kasumigaura Medical Center
Division name
Department of Anesthesiology
Zip code
305-8585
Address
2-7-4 Shimotatatsu Tsuchiura-shi IB
TEL
029-822-5050
kasumi@kasumi.hosp.go.jp
Public contact
Name of contact person
| 1st name | Taeko |
| Middle name | |
| Last name | Fukuda |
Organization
Kasumigaura Medical Center
Division name
Department of Anesthesiology
Zip code
305-8585
Address
2-7-4 Shimotatatsu Tsuchiura-shi IB
TEL
029-822-5050
Homepage URL
kasumi@kasumi.hosp.go.jp
Sponsor or person
Institute
Kasumigaura Medical Center
Institute
Department
Personal name
Funding Source
Organization
Not applicable
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kasumigaura Medical Center
Address
Ibaraki, Tsuchiura-city, Shimotakatsu 2-7-14
Tel
029-822-5050
029-822-5050
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
| 2016 | Year | 06 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 20 | Day |
Last modified on
| 2023 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025382
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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