Endoscopic Submucosal Dissection, Levobupivacaine
Conditions
Keywords
endoscopic submucosal dissection, ESD, esophagus, analgesic
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.
Interventions
DRUGLocal levobupivacaine
submucosal injection of levobupivacaine during esophageal esad
Sponsors
Laura Boer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Netherlands
Contacts
Primary ContactLaura S Boer, Degree of medicine
Outcome results
None listed