Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06611176

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Endoscopic Submucosal Dissection Levobupivacaine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMCG, Groningen, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Local levobupivacaine

Drug

submucosal injection of levobupivacaine during esophageal esad

Primary outcomes

  1. Local levobupivacaine for pain relief after Endoscopic Submucosal Dissection for esophageal lesions: a Randomized Controlled Trial

    Time frame: 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 outcomes

  1. Local levobupivacaine for pain relief after Endoscopic Submucosal Dissection for esophageal lesions: a Randomized Controlled Trial

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Laura S Boer, Degree of medicine

CONTACT

[email protected]

0887550224

Sponsors and collaborators

Lead sponsor

Laura Boer

Other

Registry information

Official study title

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

Acronym: BESD-RCT

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 24, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.