Actively Recruiting
Local LevoBupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions
Led by Laura Boer · Updated on 2024-12-02
88
Participants Needed
3
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Local LevoBupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
UMCG
Groningen, Netherlands
Actively Recruiting
2
St Antonius Hospital
Nieuwegein, Netherlands
Actively Recruiting
3
UMCU
Utrecht, Netherlands
Actively Recruiting
Research Team
L
Laura S Boer, Degree of medicine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here