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Recruiting NCT06611176

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

No phase Interventional Endoscopic Submucosal Dissection Levobupivacaine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Local levobupivacaine.
Who it may be relevant to
Registry conditions: Endoscopic Submucosal Dissection, Levobupivacaine. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Local Levobupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions: a Randomized Controlled Trial

Overview

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

  • Drug Local levobupivacaine
    submucosal injection of levobupivacaine during esophageal esad

Primary outcome measures

  • Local levobupivacaine for pain relief after Endoscopic Submucosal Dissection for esophageal lesions: a Randomized Controlled Trial [Time frame: 90min]
Secondary outcome measures (1)
  • Local levobupivacaine for pain relief after Endoscopic Submucosal Dissection for esophageal lesions: a Randomized Controlled Trial [Time frame: 14 days]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Netherlands · 3 centers
  • UMCG — Groningen
  • St Antonius Hospital — Nieuwegein
  • UMCU — Utrecht

Identifiers

NCT: NCT06611176 · 2024-510912-66-00 · 2024-510912-66-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗