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Local Levobupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions: a Randomized Controlled Trial
Led by Laura Boer · Updated on 2024-12-02
88
Participants Needed
3
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of local levobupivacaine on reducing post-procedural pain following endoscopic submucosal dissection (ESD) for esophageal lesions. This randomized controlled trial aims to compare the pain relief outcomes of levobupivacaine injection with no local pain treatment after esophageal ESD. Levobupivacaine, known for its analgesic effects and better safety profile compared to bupivacaine, has not yet been studied in this specific setting. Participants will be randomly assigned to one of two groups: one receiving no local levobupivacaine during ESD, and the other receiving a submucosal injection of levobupivacaine during the esophageal ESD procedure. The study is double-blinded, meaning neither participants nor researchers know which treatment is given. The trial focuses on assessing pain relief shortly after the procedure and up to 14 days later. During the study, participants will undergo the standard esophageal ESD procedure with or without levobupivacaine injection. Pain levels will be monitored and recorded to evaluate the effectiveness of the intervention. The primary outcome is pain relief measured 90 minutes after the procedure, with additional assessments up to 14 days post-procedure. Participants will be closely observed for safety and treatment effects throughout the study duration.
CONDITIONS
Brief 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 65 years at time of consent
- Visible lesion in the esophagus, minimum diameter of the lesion 6520 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 90 minutes
Participants receive a submucosal injection of levobupivacaine during endoscopic submucosal dissection or undergo the procedure without local levobupivacaine.
1 procedure visit (in-person)
Duration - 14 days
Participants are monitored for pain relief and recovery after the procedure.
Follow-up visits as scheduled within 14 days
Trial Site Locations
Total: 3 locations
1
UMCG
Groningen, Netherlands
Actively Recruiting
2
St Antonius Hospital
Nieuwegein, Netherlands
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3
UMCU
Utrecht, Netherlands
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Research Team
L
Laura S Boer, Degree of medicine
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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