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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030173
Receipt No. R000034457
Scientific Title Comparison of programmed intermittent bolus infusion and continuous infusion of interscalene block as postoperative analgesia after shoulder surgery
Date of disclosure of the study information 2017/12/01
Last modified on 2017/11/29

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Basic information
Public title Comparison of programmed intermittent bolus infusion and continuous infusion of interscalene block as postoperative analgesia after shoulder surgery
Acronym Comparison of programmed intermittent bolus infusion and continuous infusion of interscalene block as postoperative analgesia after shoulder surgery
Scientific Title Comparison of programmed intermittent bolus infusion and continuous infusion of interscalene block as postoperative analgesia after shoulder surgery
Scientific Title:Acronym Comparison of programmed intermittent bolus infusion and continuous infusion of interscalene block as postoperative analgesia after shoulder surgery
Region
Japan

Condition
Condition postoperative pain after shoulder surgery
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to investigate the effect of programmed intermittent bolus(PIB) infusion on the occurrence of phrenic paralysis and postoperative analgesia in patients having ISB after shoulder surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of occurrence of phrenic paralysis at 1POD morning
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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
Maneuver
Interventions/Control_1 Patients who underwent scheduled shoulder surgery were randomly allocated to have continuous ISB at constant rate (Group C) or programmed intermittent bolus ISB (Group P).Prior to induction of general anesthesia, ISB was performed with 10 ml of 0.25% levobupivacaine under ultrasound guidance, then the catheter was indwelled.For intraoperative anesthesia management, propofol, desflurane, fentanyl, remifentanil, rocuronium were used. After the emergence from general anesthesia, 0.15% levobupivacaine was started at a constant rate of 5 ml/h in group C. Ambulatory PCA pump (CADD- Legacy, Smiths Medical, Minneapolis, USA) was used for the administration of levobupivacaine.
Interventions/Control_2 In group P, 10 ml of 0.15% levobupivacaine was administered as a bolus every 8 hours from the initial bolus.
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 who undergo shoulder arthroplasty surgery can communicate without problems with cognitive function
Key exclusion criteria >Patients who do not agree with this research
>Patients who have a history of allergic reaction to levobupivacaine
>Patients who are supposed to have problems with cognitive function when interrogating NRS
Patients presenting coagulopathy on examination
>Patients with a history of allergies to tramadol and opioids, patients with acute intoxication with alcohol, sleeping agents, analgesics, opioid analgesics or psychotropics
Epilepsy patients who are not adequately controlled by treatment
>Other patients judged unsuitable for the study by other doctors
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TANAKA KUMIKO
Organization Archi Medical University
Division name Department of Anesthesiology
Zip code
Address 1-1 Karimata Yazako Nagakute city,Aichi,Japan
TEL 0561-62-3311
Email tanaka.kumiko.776@mail.aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name TANAKA KUMIKO
Organization Archie Medical University Hospital
Division name Department of Anesthesiology
Zip code
Address 1-1 Karimata Yazako Nagakute city,Aichi,Japan
TEL 0561-62-3311
Homepage URL
Email tanaka.kumiko.776@mail.aichi-med-u.ac.jp

Sponsor
Institute Archi Medical University Hospital
Institute
Department

Funding Source
Organization none
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
2017 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 12 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
2017 Year 11 Month 29 Day
Last modified on
2017 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034457

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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