Local LevoBupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions

ConditionsEndoscopic Submucosal Dissection Levobupivacaine

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorLaura Boer

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Local levobupivacaine
Drug
submucosal injection of levobupivacaine during esophageal esad

Treatment groups

88 Participants

are divided into 2 treatment groups

Group A: No levobupivacaineNo intervention 0 interventions

Group B: LevobupivacaineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Local 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

Secondary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laura Boer

Lead sponsor

St. Antonius Hospital

Sponsor institution

Source ClinicalTrials.gov

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