UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055624 |
|---|---|
| Receipt number | R000063462 |
| Scientific Title | Effect of local anesthetic concentration on the duration of ultrasound guided ankle block with ropivacaine |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/03/30 17:32:33 |
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Basic information
Public title
Effect of local anesthetic concentration on the duration of ultrasound guided ankle block with ropivacaine
Acronym
Effect of local anesthetic concentration on the duration of ultrasound guided ankle block with ropivacaine
Scientific Title
Effect of local anesthetic concentration on the duration of ultrasound guided ankle block with ropivacaine
Scientific Title:Acronym
Effect of local anesthetic concentration on the duration of ultrasound guided ankle block with ropivacaine
Region
| Japan |
Condition
Condition
postoperative pain after hallux valgus repair surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ankle block is recommended in PROSPECT published by ESRA (The European Society of Regional Anaesthesia and Pain Therapy) for hallux valgus repair surgery.
The sciatic nerve block with popliteal technique or ankle block is the most commonly peripheral block for hallux valgus repair surgery. Sciatic nerve block may give the patient ankle joint motor block. On the other hand, ankle block provides analgesia without the motor block.
Although there are several articles comparing the efficacy of sciatic nerve blocks and ankle blocks, they all use the same concentration of local anesthetics. The papers insists that ankle block is inferior to sciatic nerve block about analgesia and duration. However, since ankle block does not give the motor block, in theory, it is possible to use a higher concentration of local anesthetic for ankle block than sciatic nerve block and still have no motor dysfunction problems.
It has been reported that an increase in the amount of local anesthetic during nerve block is related to the duration. Increasing the ropivacaine concentration from 0.375% to 0.75% in brachial plexus block increased the block duration from 10.75 (9.75-14.0) hours to 13.75 (10.5-21.0) hours. The other report states that the duration of the ankle block is 15.4 +/- 8.0 hours when 30 ml of 0.5% ropivacaine is used.
In ankle blocks, local anesthetics are administered in a narrow compartment, so increasing the fluid volume increases the risk of ischemia. High concentrations of local anesthetics have been reported to cause reversible muscle damage in vitro, but there have been only a few reports in practice. In addition, bupivacaine is considered more myotoxic than ropivacaine. Therefore, we decided to use ropivacaine in this study.
For these reasons, we decided to investigate the difference in duration of ankle block depending on the local anesthetic concentration in order to determine the most appropriate concentration of local anesthetics for ankle block.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time elapsed between the block procedure and the first intravenous analgesic request
(the unused rate in each group when the patients do not request analgesics exclude our institutional standard multimodal analgesic regimen)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
For patients in the 0.25% ropivacaine use group, we prepare 17 ml of 0.25% ropivacaine.
Each drug solution will be prepared by a person, who is not the anesthesiologist or block provider.
The ankle block is performed after general anesthesia for the surgery. All five branches of the target nerve (deep peroneal nerve, superficial peroneal nerve, tibial nerve, sural nerve, and saphenous nerve) are performed under ultrasound guidance. The dose of ropivacaine is 3 ml per nerve for the four branches (deep peroneal, superficial peroneal, sural, and saphenous nerves) and 5 ml for the tibial nerve; the total dose for the five nerve blocks is 17 ml.
Thus, the dose of ropivacaine for the 0.25% ropivacaine group would be 42.5 mg. These doses are for use within insurance coverage (up to 300 mg of ropivacaine per 40 ml dose).
Ankle block is performed only once for each patient.
Interventions/Control_2
For patients in the 0.75% ropivacaine group, we prepare 17 ml of 0.75% ropivacaine.
Each drug solution will be prepared by a person, who is not the anesthesiologist or block provider.
The ankle block is performed after general anesthesia for the surgery. All five branches of the target nerve (deep peroneal nerve, superficial peroneal nerve, tibial nerve, sural nerve, and saphenous nerve) are performed under ultrasound guidance. The dose of ropivacaine is 3 ml per nerve for the four branches (deep peroneal, superficial peroneal, sural, and saphenous nerves) and 5 ml for the tibial nerve; the total dose for the five nerve blocks is 17 ml.
Thus, the dose of ropivacaine for the 0.75% ropivacaine group would be 127.5 mg. These doses are for use within insurance coverage (up to 300 mg of ropivacaine per 40 ml dose).
Ankle block is performed only once for each patient.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) The patient can move his/her ankle joint following to our instructions
(2) The patient can understand Japanese language
Key exclusion criteria
(1) Patients weighing less than 42 kg
(2) Patients with coagulation disorders
(3) Peripheral neuropathy or chronic pain syndrome
(4) Infection at the site of insertion
(5) Allergy to local anesthetics
(6) Patient refusal
(7) Patients with renal function disorder(eGFR <60), impaired hepatic function (AST, ALT and Gamma-GTP are outside the reference values)
(8) Patients diagnosed with diabetes mellitus
(9) Patients deemed inappropriate as research subjects by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tomoki |
| Middle name | |
| Last name | Sasakawa |
Organization
Tokyo women's medical university
Division name
the department of anesthesia
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
sasakawa.tomoki@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Tomoki |
| Middle name | |
| Last name | Sasakawa |
Organization
Tokyo women's medical university
Division name
the department of anesthesia
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
sasakawa.tomoki@twmu.ac.jp
Sponsor or person
Institute
Tokyo women's medical university
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Tokyo women's medical university
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
Tel
03-3353-8111
rinri.bm@twmu.ac.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
| 2024 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | 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
| 2024 | Year | 09 | Month | 26 | Day |
Last modified on
| 2025 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063462
