UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062083 |
|---|---|
| Receipt number | R000071035 |
| Scientific Title | Analgesic and Motor Responses After Epidural Rescue With Alkalinized 0.3 Percent Lidocaine-Epinephrine for Breakthrough Pain During Advanced Labor A Single-Center Retrospective Cohort Study |
| Date of disclosure of the study information | 2026/06/28 |
| Last modified on | 2026/08/11 00:39:42 |
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Basic information
Public title
Analgesic and Motor Responses After Epidural Rescue With Alkalinized 0.3% Lidocaine-Epinephrine for Breakthrough Pain During Advanced Labor
Acronym
Epidural Rescue in Advanced Labor Study
Scientific Title
Analgesic and Motor Responses After Epidural Rescue With Alkalinized 0.3 Percent Lidocaine-Epinephrine for Breakthrough Pain During Advanced Labor A Single-Center Retrospective Cohort Study
Scientific Title:Acronym
Epidural Rescue in Advanced Labor 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 describe recorded short-term analgesic, sensory, and motor responses and retrospectively documented maternal, fetal, neurological, and feasibility events following a small-volume epidural rescue bolus of alkalinized 0.3% lidocaine-epinephrine in women with breakthrough pain during advanced labor and clinically reliable epidural catheters.
Basic objectives2
Others
Basic objectives -Others
Descriptive evaluation of analgesic, sensory, motor, and documented clinical responses
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Within-patient change in contraction pain measured on a 0-100 mm visual analog scale from immediately before the study rescue bolus to 5 to 15 minutes after administration.
Key secondary outcomes
Prespecified immediate secondary outcomes: any VAS reduction from immediately before to 5 to 15 minutes after the study rescue bolus; post-bolus VAS equal to 0 mm; post-bolus VAS less than or equal to 10 mm; changes in the upper and lower boundaries of cold sensory loss; worsening of the modified Bromage score; new motor block among women with a baseline modified Bromage score of 0; and post-bolus modified Bromage score greater than or equal to 2. Other documented outcomes: maternal hypotension 5 to 15 minutes after the study rescue bolus; new fetal heart rate abnormality after the study rescue bolus and before delivery; symptoms suggestive of local anesthetic systemic toxicity; additional clinician-administered neuraxial rescue for labor pain; postpartum neurological symptoms; visible precipitate after preparation; mode of delivery; operative vaginal delivery; fundal pressure; and 1- and 5-minute Apgar scores. Post hoc exploratory outcomes: delivery VAS analyses restricted to vaginal deliveries; relative VAS reductions of 30 percent or more and 50 percent or more; baseline-restricted analyses; robustness analyses; and subgroup analyses.
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 August 19, 2022 and March 18, 2026. 2) Women who developed breakthrough pain after previously satisfactory neuraxial analgesia. 3) Cervical dilation of at least 7 cm, with the attending obstetrician or midwife judging that labor was progressing rapidly and that delivery was likely within approximately 1 hour. 4) Women who received epidural rescue administration of alkalinized 0.3% lidocaine-epinephrine through an indwelling epidural catheter for breakthrough pain.
Key exclusion criteria
1) Recurrent clinician-administered epidural boluses at intervals of 90 minutes or less before the study rescue bolus, indicating 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 252-0375, 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
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 252-0375, 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
北里大学病院(神奈川県) Kitasato University Hospital
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
| 2026 | Year | 06 | Month | 28 | Day |
Date trial data considered complete
| 2026 | Year | 06 | Month | 28 | Day |
Date analysis concluded
| 2026 | Year | 08 | Month | 10 | Day |
Other
Other related information
This was a single-center retrospective cohort study using existing medical records. The clinical observation period was from August 19, 2022 to March 18, 2026. The retrospective research protocol, including the primary outcome and principal statistical approach, was finalized on May 11, 2026 before data extraction and statistical analysis. The study was registered with UMIN on June 27, 2026 after completion of the clinical observation period. The protocol fixation date in the UMIN registration is shown as August 19, 2022 because this date was entered as the beginning of the clinical observation period at initial registration and cannot be changed after formal registration under the UMIN system.
Cases were identified from medication administration and anesthesia records regardless of the recorded responses or documentation completeness. Documentation completeness was not an eligibility criterion. For women with more than one delivery during the study period, only the first delivery was included. No formal a priori sample size calculation was performed, and all eligible cases identified during the fixed study period were included in the analysis.
Paired VAS values immediately before and 5 to 15 minutes after the study rescue bolus were primarily analyzed using the Wilcoxon matched-pair signed-rank test. Mean within-patient changes and 95 percent confidence intervals were also calculated to quantify magnitude and precision. Clinical events were summarized descriptively because no comparator was available. No values were imputed.
Delivery VAS analyses restricted to vaginal deliveries, relative VAS reductions of 30 percent or more and 50 percent or more, baseline VAS restricted analyses, robustness analyses, and subgroup analyses were conducted as post hoc exploratory analyses.
Management information
Registered date
| 2026 | Year | 06 | Month | 27 | Day |
Last modified on
| 2026 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071035
