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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaura Boer

About this trial

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.

Eligibility criteria

Qualifiers

Patients age ≥18 years at time of consent

Visible lesion in the esophagus, minimum diameter of the lesion ≥20 mm

Scheduled for esophageal ESD

Informed consent

Disqualifiers

Presence of multiple lesions requiring two or more separate endoscopic resections

History of esophageal surgery other than fundoplications

History of esophageal ablation therapy

History of radiotherapy of the esophagus

Trial design

Treatments tested in this trial

  • Local levobupivacaine

Treatment groups

88 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Laura Boer

Lead sponsor

St. Antonius Hospital

Sponsor institution