UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062416 |
|---|---|
| Receipt number | R000071428 |
| Scientific Title | A Prospective Single-Center Observational Study of Ultrasound-Guided Adductor Canal Block Combined with Popliteal Plexus Block on Rescue Analgesic Use Within 24 Hours and Perioperative Outcomes in Patients Undergoing Tibial Plateau Fracture Surgery |
| Date of disclosure of the study information | 2026/07/31 |
| Last modified on | 2026/07/31 10:39:07 |
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Basic information
Public title
Prospective observational study of ultrasound-guided adductor canal block combined with popliteal plexus block for postoperative analgesia after tibial plateau fracture surgery
Acronym
APP-TPF Study
Scientific Title
A Prospective Single-Center Observational Study of Ultrasound-Guided Adductor Canal Block Combined with Popliteal Plexus Block on Rescue Analgesic Use Within 24 Hours and Perioperative Outcomes in Patients Undergoing Tibial Plateau Fracture Surgery
Scientific Title:Acronym
APP-TPF Study
Region
| Japan |
Condition
Condition
tibial plateau fracture
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate the proportion of patients requiring rescue analgesia (NSAID administration or initiation of intravenous patient-controlled analgesia [IVPCA]) within 24 hours after surgery, as well as perioperative outcomes, in patients undergoing tibial plateau fracture surgery who receive ultrasound-guided adductor canal block (ACB) combined with popliteal plexus block (PPB).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of patients requiring rescue analgesia (NSAID administration or initiation of intravenous patient-controlled analgesia [IVPCA]) within 24 hours after surgery
Key secondary outcomes
Postoperative pain intensity (Numeric Rating Scale), motor function, block-related adverse events (local anesthetic systemic toxicity, neurological complications, vascular puncture, infection, and hematoma), postoperative nausea and vomiting, postoperative delirium, time to first ambulation, and length of hospital stay.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
After induction of general anesthesia, ultrasound-guided adductor canal block (ACB) and popliteal plexus block (PPB) will be performed using 10 mL of 0.25% levobupivacaine for each block (total 20 mL, 50 mg) without adjuvants. Acetaminophen will be administered every 6 hours postoperatively. Rescue analgesia will consist of NSAID administration, followed by intravenous patient-controlled analgesia (IVPCA) if required.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Age 18 years or older.
2.Patients undergoing open reduction and internal fixation for tibial plateau fracture under general anesthesia at Iwate Prefectural Ofunato Hospital.
3.Able to understand the Numeric Rating Scale (NRS).
4.Written informed consent obtained from the patient.
Key exclusion criteria
1.Refusal to participate.
2.Allergy to local anesthetics.
3.Infection at the injection site.
4.Coagulopathy or antithrombotic therapy contraindicating peripheral nerve block.
5.Severe pre-existing neurological deficits.
6.Suspected or confirmed acute compartment syndrome or planned fasciotomy.
7.Inability to provide written informed consent.
8.Pregnancy.
9.Patients considered unsuitable by the attending physician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kento |
| Middle name | |
| Last name | Oikawa |
Organization
Iwate Prefectural Ofunato Hospital
Division name
Anesthesiology
Zip code
0220002
Address
10-1 Yamamagoe, Ofunato-cho, Ofunato, Iwate 022-0002, Japan
TEL
0192261111
k-oikawa1994@outlook.jp
Public contact
Name of contact person
| 1st name | Kento |
| Middle name | |
| Last name | Oikawa |
Organization
Iwate Prefectural Ofunato Hospital
Division name
Department of Anesthesiology
Zip code
0220002
Address
10-1 Yamamagoe, Ofunato-cho, Ofunato, Iwate 022-0002, Japan
TEL
0192261111
Homepage URL
k-oikawa1994@outlook.jp
Sponsor or person
Institute
Iwate Prefectural Ofunato Hospital
Institute
Department
Personal name
Kento Oikawa
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
Ethics Committee, Iwate Prefectural Ofunato Hospital
Address
10-1 Yamamagoe, Ofunato-cho, Ofunato, Iwate 022-0002, Japan
Tel
0192261111
k-oikawa1994@outlook.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
岩手県立大船渡病院（岩手県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 31 | 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 | 07 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2031 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2031 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2031 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 31 | Day |
Last modified on
| 2026 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071428
