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

NCT06611176 | Recruiting

• 1 other identifier: 2024-510912-66-00
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Endoscopic Submucosal Dissection; Levobupivacaine

Keywords

endoscopic submucosal dissection; ESD; esophagus; analgesic

Outcome Measures

Primary Outcomes (1)

• 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

  90min

Secondary Outcomes (1)

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

  14 days

Study Arms (2)

No levobupivacaine

NO INTERVENTION

ESD without local levobupivacaine

Levobupivacaine

EXPERIMENTAL

levobupivacaine submucosally injected during esopahgeal esd

Drug: Local levobupivacaine

Interventions

Local levobupivacaine DRUG

submucosal injection of levobupivacaine during esophageal esad

Levobupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laura Boer: lead

Study Sites (3)

UMCG

Groningen, Netherlands

RECRUITING

St Antonius Hospital

Nieuwegein, Netherlands

RECRUITING

UMCU

Utrecht, Netherlands

RECRUITING

Central Study Contacts

Laura S Boer, Degree of medicine

CONTACT

0887550224; l.boer1@antoniusziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 24, 2024
• Study Start: October 24, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 30, 2026
• Last Updated: December 2, 2024

Record last verified: 2024-09

Locations

NL (3)