UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061112 |
|---|---|
| Receipt number | R000069931 |
| Scientific Title | Comparison of postoperative analgesia between interscalene and supraclavicular brachial plexus block for proximal humerus fracture surgery |
| Date of disclosure of the study information | 2026/04/06 |
| Last modified on | 2026/03/31 13:37:45 |
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Basic information
Public title
Comparison of postoperative analgesia between interscalene and supraclavicular brachial plexus block for proximal humerus fracture surgery
Acronym
Comparison of postoperative analgesia between interscalene and supraclavicular brachial plexus block for proximal humerus fracture surgery
Scientific Title
Comparison of postoperative analgesia between interscalene and supraclavicular brachial plexus block for proximal humerus fracture surgery
Scientific Title:Acronym
Comparison of postoperative analgesia between interscalene and supraclavicular brachial plexus block for proximal humerus fracture surgery
Region
| Japan |
Condition
Condition
proximal humerus fracture
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A comparative study of the postoperative analgesic effects of the interscalene nerve block (ISB) and the supraclavicular brachial plexus block (SCB) in patients with proximal humeral fractures
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes over time in resting NRS score
Key secondary outcomes
NRS score at 0, 1, 3, 6, 12, 24 hours postoperatively, frequency of use of rescue analgesics, postoperative nausea and vomiting, SpO2, postoperative ultrasound to check for pneumothorax, adverse events
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The procedure is performed under total intravenous anesthesia with remimazolam and remifentanil, with the dosage adjusted to maintain a BIS score within the range of 40-60. Fentanyl 250 ug is administered concurrently as an intraoperative analgesic. The nerve block is performed prior to induction of anesthesia. In the ISB group, 20 mL (50 mg) of 0.25% levobupivacaine is administered for the ultrasound-guided ISB. At the end of the surgery, 15 mg/kg of acetaminophen is administered, with additional doses given at 6, 12, 18, and 24 hours postoperatively. If pain persists despite this, rescue analgesics are administered.
Interventions/Control_2
The procedure is performed under total intravenous anesthesia with remimazolam and remifentanil, with the dosage adjusted to maintain a BIS score within the range of 40-60. Fentanyl 250 ug is administered concurrently as an intraoperative analgesic. The nerve block is performed prior to induction of anesthesia. In the SCB group, 20 mL (50 mg) of 0.25% levobupivacaine is administered for the ultrasound-guided SCB. At the end of the surgery, 15 mg/kg of acetaminophen is administered, with additional doses given at 6, 12, 18, and 24 hours postoperatively. If pain persists despite this, rescue analgesics are administered.
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
Adult patients with an ASA-PS 1 or 2 undergoing surgery for a proximal humerus fracture
Key exclusion criteria
Patients with cardiac dysfunction, liver dysfunction, Kidney dysfunction, respiratory dysfunction, allergy to the medication used, local infection at the puncture site and difficulty communicating
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Terao |
Organization
Nagasaki Rousai Hospital
Division name
Department of Anesthesiology
Zip code
857-0134
Address
2-12-5 Setogoe, Sasebo, Nagasaki, Japan
TEL
0956-49-2191
yoterao@nagasakih.johas.go.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Terao |
Organization
Nagasaki Rousai Hospital
Division name
Department of Anesthesiology
Zip code
857-0134
Address
2-12-5 Setogoe, Sasebo, Nagasaki
TEL
0956-49-2191
Homepage URL
yoterao@nagasakih.johas.go.jp
Sponsor or person
Institute
Department of Anesthesiology, Nagasaki Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Research funds to promote the hospital functions of Japan Organization of Occupational Health and Safety
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki Rosai Hospital
Address
2-12-5 Setogoe, Sasebo, Nagasaki, Japan
Tel
0956-49-2191
shom@nagasakih.johas.go.jp
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
| 2026 | Year | 04 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 03 | Month | 31 | Day |
Last modified on
| 2026 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069931
