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

NCT ID: NCT06611176

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-24

Study Completion Date

2026-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Endoscopic Submucosal Dissection Levobupivacaine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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No levobupivacaine

ESD without local levobupivacaine

Group Type NO_INTERVENTION

No interventions assigned to this group

Levobupivacaine

levobupivacaine submucosally injected during esopahgeal esd

Group Type EXPERIMENTAL

Local levobupivacaine

Intervention Type DRUG

submucosal injection of levobupivacaine during esophageal esad

Interventions

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Local levobupivacaine

submucosal injection of levobupivacaine during esophageal esad

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laura Boer

OTHER

Sponsor Role lead

Responsible Party

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Laura Boer

Principle Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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UMCG

Groningen, , Netherlands

Site Status RECRUITING

St Antonius Hospital

Nieuwegein, , Netherlands

Site Status RECRUITING

UMCU

Utrecht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Laura S Boer, Degree of medicine

Role: CONTACT

[email protected]
0887550224

Facility Contacts

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S, Degree of medicine

Role: primary

Other Identifiers

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2024-510912-66-00

Identifier Type: CTIS

Identifier Source: secondary_id

2024-510912-66-00

Identifier Type: -

Identifier Source: org_study_id