Using levobupivacaine to relieve pain after esophageal surgery
Local Levobupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions: a Randomized Controlled Trial
This study is testing if using levobupivacaine can help reduce pain after esophageal surgery for adults with certain esophageal conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Antonius Hospital Academic / other |
| Locations | 3 sites (Groningen and 2 other locations) |
| Trial ID | NCT06611176 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of local levobupivacaine application for reducing post-procedural pain in patients undergoing endoscopic submucosal dissection (ESD) for esophageal lesions. ESD is a procedure often performed for (pre)cancerous lesions, which can lead to significant chest pain afterward. Previous research has indicated that local bupivacaine can effectively alleviate pain after similar procedures, and this study aims to determine if levobupivacaine, which has a better safety profile, can provide similar benefits. The trial will involve patients aged 18 and older with specific eligibility criteria related to their esophageal condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a visible esophageal lesion of at least 20 mm scheduled for ESD.
Not a fit: Patients with multiple lesions requiring separate resections, severe medical comorbidities, or those with a history of esophageal surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce post-procedural pain for patients undergoing esophageal ESD, improving their recovery experience.
How similar studies have performed: While local bupivacaine has shown success in similar procedures, this specific application of levobupivacaine after esophageal ESD is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Groningen and 2 other locations
- Umcg — Groningen, Netherlands (Recruiting)
- St Antonius Hospital — Nieuwegein, Netherlands (Recruiting)
- Umcu — Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Laura S Boer, Degree of medicine
- Email: l.boer1@antoniusziekenhuis.nl
- Phone: 0887550224
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.