UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000022372
Receipt No. 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 2016/06/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Taeko Fukuda
Organization Kasumigaura Medical Center
Division name Department of Anesthesiology
Zip code
Address 2-7-4 Shimotatatsu Tsuchiura-shi IB
TEL 029-822-5050
Email kasumi@kasumi.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taeko Fukuda
Organization Kasumigaura Medical Center
Division name Department of Anesthesiology
Zip code
Address 2-7-4 Shimotatatsu Tsuchiura-shi IB
TEL 029-822-5050
Homepage URL
Email kasumi@kasumi.hosp.go.jp

Sponsor
Institute Kasumigaura Medical Center
Institute
Department

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
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
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
Date of protocol fixation
2016 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 01 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
2016 Year 05 Month 20 Day
Last modified on
2016 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025382

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.