Local LevoBupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions

Study acronym: BESD-RCT
StatusUnknown
PhaseNot applicable
SponsorLaura Boer
Started

Record status This record was last updated December 2, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

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Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Sep 30, 2024 to Oct 24, 2024
    v4
  3. Study Identification, Study Status, Sponsor/Collaborators, Oversightv3
  4. Study Identification, Study Status, Sponsor/Collaborators, Oversightv2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Endoscopic submucosal dissection (ESD) is commonly performed for (pre)cancerous lesions in the esophagus. Following ESD, post-procedural chest pain is seen in many patients. Studies have shown that local bupivacaine (BP) into the residual submucosal layer of the resection wound after gastric ESD could reduce post-procedural pain rates effectively. Levobupivacaine (LB) is equipotent to BP regarding analgesic effects, but has a better safety profile. No studies have been performed to evaluate the efficacy of LB after esophageal ESD to reduce pain. Therefore, we want to evaluate the effect on post-procedural pain of local application of LB during esophageal ESD.
Trial Details
NCT Number NCT06611176
Lead Sponsor Laura Boer
Conditions
(from sponsor)		 Endoscopic Submucosal Dissection, Levobupivacaine
Enrollment 88 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov