Local LevoBupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions (BESD-RCT)

November 27, 2024 updated by: Laura Boer

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Groningen, Netherlands
        • Recruiting
        • UMCG
      • Nieuwegein, Netherlands
        • Recruiting
        • St Antonius hospital
      • Utrecht, Netherlands
        • Recruiting
        • UMCU
        • Contact:
          • S, Degree of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No levobupivacaine
ESD without local levobupivacaine
Experimental: Levobupivacaine
levobupivacaine submucosally injected during esopahgeal esd
Drug: Local levobupivacaine
submucosal injection of levobupivacaine during esophageal esad

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laura Boer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-510912-66-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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