Local LevoBupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions
- Conditions
- Endoscopic Submucosal DissectionLevobupivacaine
- Interventions
- Registration Number
- NCT06611176
- Lead Sponsor
- Laura Boer
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 88
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Levobupivacaine Local levobupivacaine levobupivacaine submucosally injected during esopahgeal esd
- Primary Outcome Measures
Name Time Method Local levobupivacaine for pain relief after Endoscopic Submucosal Dissection for esophageal lesions: a Randomized Controlled Trial 90min The proportion of patients with major pain within 90 minutes after the procedure comparing the LB and non-LB group. Major pain is defined as a pain score of 4 or higher on a 0-10 Numeric Rating Scale (NRS). The highest pain score reported at any of the three pre-defined time points (30, 60, or 90 minutes after the procedure) will be used to determine if a patient experienced major pain
- Secondary Outcome Measures
Name Time Method Local levobupivacaine for pain relief after Endoscopic Submucosal Dissection for esophageal lesions: a Randomized Controlled Trial 14 days Pain scores based on a 0-10 NRS within 90 minutes after the procedure, 6 hours after the procedure and thereafter daily up to day 14.
* Cumulative pain throughout 14 days based on the area under the curve of a pain versus time plot.
* Duration of pain, defined as the number of days until pain scores were reported to be 0 on all following days.
* Daily and overall use of analgesics up to day 14 post-procedurally registered in a patient diary (electronic or on paper).
* Length of hospital stay in days
* Incidence of serious adverse events related to LB administration (including allergic reactions to LB).
* Incidence of adverse events related to LB ad ministration (including allergic reactions to LB).
Trial Locations
- Locations (3)
UMCG
🇳🇱Groningen, Netherlands
St Antonius Hospital
🇳🇱Nieuwegein, Netherlands
UMCU
🇳🇱Utrecht, Netherlands
UMCG🇳🇱Groningen, Netherlands