Tokyo, June 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062083) titled 'A retrospective study of an alkalinized low-concentration lidocaine preparation for breakthrough pain during labor analgesia' on June 28.

Study Type: Observational

Primary Sponsor: Institute - Kitasato University

Condition: Condition - Pregnant women with breakthrough pain during neuraxial labor analgesia in advanced labor Classification by malignancy - Others Genomic information - NO

Objective: 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

Eligibility: Age-lower limit - 18 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 Size - 150

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071035

Disclaimer: Curated by HT Syndication.