Endoscopic Submucosal DissectionBESD-RCTNCT06611176
Local LevoBupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions
A study testing Local levobupivacaine in people with Endoscopic Submucosal Dissection and Levobupivacaine, run by Laura Boer at 3 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Submucosal Dissection, Levobupivacaine
- What is being tested?
- Local levobupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 3 sitesNetherlands
- Study dates
- 24 Oct 2024to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites, 3 recruiting
- Recruiting
UMCG
Groningen
- Recruiting
St Antonius Hospital
Nieuwegein
- Recruiting
UMCU
Utrecht
S, Degree of medicine
About this study
Official title: 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.
- Conditions
- Endoscopic Submucosal Dissection, Levobupivacaine
- Being tested
- Local levobupivacaine
- Keywords
- endoscopic submucosal dissection, ESD, esophagus, analgesic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local levobupivacaineDrug
submucosal injection of levobupivacaine during esophageal esad
| Study group | Role | What they receive |
|---|---|---|
| No levobupivacaine | No intervention | ESD without local levobupivacaine |
| Levobupivacaine | Experimental | levobupivacaine submucosally injected during esopahgeal esd Receives: Drug: Local levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90min
Secondary outcomes (1)
Local levobupivacaine for pain relief after Endoscopic Submucosal Dissection for esophageal lesions: a Randomized Controlled Trial
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).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start24 Oct 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Submucosal DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laura Boer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laura Boer, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611176
- Sponsor's protocol ID
- 2024-510912-66-00
- Other IDs
- 2024-510912-66-00
- Acronym
- BESD-RCT
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Levobupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06611176
- Acronym / sponsor ID
- BESD-RCT / 2024-510912-66-00
- Conditions
- Endoscopic Submucosal Dissection, Levobupivacaine
- Keywords
- endoscopic submucosal dissection, ESD, esophagus, analgesic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Laura BoerUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No levobupivacaine | No intervention | –ESD without local levobupivacaine |
| Levobupivacaine | Experimental | Drug: Local levobupivacainelevobupivacaine submucosally injected during esopahgeal esd |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local levobupivacainesubmucosal injection of levobupivacaine during esophageal esad | Drug | Levobupivacaine |
Primary outcome
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
1 secondary outcome
Local levobupivacaine for pain relief after Endoscopic Submucosal Dissection for esophageal lesions: a Randomized Controlled Trial
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local levobupivacaine in people with Endoscopic Submucosal Dissection and Levobupivacaine, run by Laura Boer at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura S Boer, Degree of medicine (0887550224, l.boer1@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local levobupivacaine for pain relief after Endoscopic Submucosal Dissection for esophageal lesions: a Randomized Controlled Trial (time frame: 90min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.