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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-510912-66-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No levobupivacaine | No Intervention | ESD without local levobupivacaine | |
| Levobupivacaine | Experimental | levobupivacaine submucosally injected during esopahgeal esd |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local levobupivacaine | Drug | submucosal injection of levobupivacaine during esophageal esad |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura S Boer, Degree of medicine | Contact | 0887550224 | l.boer1@antoniusziekenhuis.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMCG | Recruiting | Groningen | Netherlands | |||
| St Antonius Hospital |
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| 14 days |
| Recruiting |
| Nieuwegein |
| Netherlands |
| UMCU | Recruiting | Utrecht | Netherlands |
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