UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062083 |
|---|---|
| Receipt number | R000071035 |
| Scientific Title | Effects of an Alkalinized Low-Concentration Lidocaine Preparation for Breakthrough Pain During Neuraxial Labor Analgesia: A Single-Center Retrospective Observational Study |
| Date of disclosure of the study information | 2026/06/28 |
| Last modified on | 2026/06/28 01:06:49 |
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Basic information
Public title
A retrospective study of an alkalinized low-concentration lidocaine preparation for breakthrough pain during labor analgesia
Acronym
Alkalinized Low-Concentration Lidocaine Labor Analgesia Study
Scientific Title
Effects of an Alkalinized Low-Concentration Lidocaine Preparation for Breakthrough Pain During Neuraxial Labor Analgesia: A Single-Center Retrospective Observational Study
Scientific Title:Acronym
0.3L Labor Analgesia Study
Region
| Japan |
Condition
Condition
Pregnant women with breakthrough pain during neuraxial labor analgesia in advanced labor
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively evaluate pain scores before and after treatment, pain at delivery, cold sensory levels, motor block, and delivery and neonatal outcomes in women with breakthrough pain during advanced labor who received epidural rescue administration of alkalinized 0.3 % lidocaine with epinephrine during neuraxial labor analgesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Within patient change in the 0 to 100 mm VAS pain score from immediately before administration of Alkalinized 0.3% Lidocaine with Epinephrine to 5 to 15 minutes after administration.
Key secondary outcomes
VAS at delivery; post-treatment VAS=0; post-treatment VAS less 10 mm; 30% reduction and 50% reduction VAS reductions; changes in upper and lower cold sensory boundaries; worsening of modified Bromage score; new motor block; post-treatment Bromage score more 2; mode of delivery; operative vaginal delivery rate; fundal pressure; 1- and 5-minute Apgar scores; postpartum neurological symptoms; post administration hypotension; symptoms of local anesthetic toxicity; the presence or absence of precipitates in the solution.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Women who received neuraxial labor analgesia at Kitasato University Hospital between 19 August 2022 and 18 March 2026. 2) Women who developed breakthrough pain after previously satisfactory epidural analgesia through an indwelling epidural catheter. 3) Cervical dilation more 7 cm, with the attending obstetrician or midwife judging that labor had entered a rapidly progressing phase and that delivery was likely within approximately 1 hour. 4) Women who received epidural rescue administration of alkalinized 0.3% lidocaine with epinephrine for breakthrough pain. 5) Cases with retrievable medical record data including pre-treatment and 5 to 15 min post treatment VAS, cold sensory levels, and modified Bromage scores.
Key exclusion criteria
1) Recurrent breakthrough pain requiring clinician administered epidural boluses at least once per 90 minutes before the index treatment, suggesting probable epidural catheter dysfunction. 2) Pre existing neurological disorders. 3) Cognitive or developmental impairment precluding reliable analgesic assessment. 4) Previous spinal surgery. 5) Patients who declined participation through the opt out procedure.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Hyuga |
Organization
Kitasato University
Division name
Department of Anesthesiology, School of Medicine
Zip code
2520375
Address
1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa Prefecture
TEL
0427788606
shyuga@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Hyuga |
Organization
Kitasato university
Division name
Department of Anesthesiology, School of Medicine
Zip code
2520375
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan
TEL
0427788606
Homepage URL
shyuga@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Medical Ethics Organization
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan
Tel
0427788111
rinrib@med.kitasato-u.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
| 2026 | Year | 06 | Month | 28 | 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
143
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single center retrospective observational study using existing medical records. The exposure is epidural rescue administration of alkalinized 0.3% lidocaine with epinephrine for breakthrough pain in advanced labor. The primary outcome is the change in VAS from pre-treatment to 5 to 15 minutes post-treatment. Related outcomes include VAS at delivery, cold sensory levels, modified Bromage score, mode of delivery, Apgar scores and etc. Consecutive eligible cases during the study period are included; no random sampling or case-control sampling is used.
Management information
Registered date
| 2026 | Year | 06 | Month | 27 | Day |
Last modified on
| 2026 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071035
