Local LevoBupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions (BESD-RCT)

Laura Boer

Status

Enrolling

Conditions

Levobupivacaine

Endoscopic Submucosal Dissection

Treatments

Drug: Local levobupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT06611176

2024-510912-66-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment

88 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
Esophageal varices
Prior endoscopic resection in the same area
Uncontrolled coagulopathy
Severe medical comorbidities precluding endoscopy
Allergy to LB or other amide-type local anaesthesia
Current regular use of opioids
Other aetiology causing pain similar to post-ESD pain
Inability to assess pain due to severe psychiatric or neurological disease
Insufficient command of Dutch language
Brugada syndrome
Incapacitated patients