Local Levobupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions: a Randomized Controlled Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
UMCG
RECRUITING
Groningen
St Antonius Hospital
RECRUITING
Nieuwegein
UMCU
RECRUITING
Utrecht
Contact Information
Primary
Laura S Boer, Degree of medicine
l.boer1@antoniusziekenhuis.nl
0887550224
Time Frame
Start Date: 2024-10-24
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 88
Treatments
No_intervention: No levobupivacaine
ESD without local levobupivacaine
Experimental: Levobupivacaine
levobupivacaine submucosally injected during esopahgeal esd
Related Therapeutic Areas
Sponsors
Leads: Laura Boer

This content was sourced from clinicaltrials.gov