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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
88
submucosal injection of levobupivacaine during esophageal esad
UMCG
Groningen, Netherlands
RECRUITINGSt Antonius Hospital
Nieuwegein, Netherlands
RECRUITINGUMCU
Utrecht, Netherlands
RECRUITINGLocal levobupivacaine for pain relief after Endoscopic Submucosal Dissection for esophageal lesions: a Randomized Controlled Trial
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
Time frame: 90min
Local levobupivacaine for pain relief after Endoscopic Submucosal Dissection for esophageal lesions: a Randomized Controlled Trial
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).
Time frame: 14 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.