Status:
RECRUITING
Local LevoBupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions
Lead Sponsor:
Laura Boer
Conditions:
Endoscopic Submucosal Dissection
Levobupivacaine
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 lo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT06611176
Start Date
October 24 2024
End Date
March 30 2026
Last Update
December 2 2024
Active Locations (3)
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1
UMCG
Groningen, Netherlands
2
St Antonius Hospital
Nieuwegein, Netherlands
3
UMCU
Utrecht, Netherlands