LEVOBUPIVACAINE HYDROCHLORIDE for Visible esophageal lesions (pre-cancerous)

Inclusion criteria

• {"criterion_text":"-\tPatients age ≥18 years at time of consent\n-\tVisible lesion in the esophagus, minimum diameter of the lesion ≥20 mm\n-\tScheduled for esophageal ESD\n-\tInformed consent"}

Exclusion criteria

• {"criterion_text":"-\tPresence of multiple lesions requiring two or more separate endoscopic resections\n-\tAllergy to LB or other amide-type local anaesthesia\n-\tCurrent regular use of opioids\n-\tOther aetiology causing pain similar to post-ESD pain\n-\tPregnancy or breast feeding\n-\tInability to assess pain due to severe psychiatric or neurological disease\n-\tInsufficient command of Dutch language\n-\tHistory of esophageal surgery other than fundoplications\n-\tHistory of esophageal ablation therapy\n-\tHistory of radiotherapy of the esophagus\n-\tEsophageal varices\n-\tPrior endoscopic resection in the same area\n-\tBrugada syndrome\n-\tUncontrolled coagulopathy\n-\tSevere medical comorbidities precluding endoscopy"}

Primary endpoints

• {"endpoint_text":"- 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 score of four or higher based on a 0-10 NRS. The peak pain score (maximum reported pain score) at one of the three pre-defined time points of 30, 60 and 90 minutes after the procedure will be used for this.","definition_or_measurement_approach":"Major pain defined as NRS score ≥4 on a 0-10 numeric rating scale; use the peak (maximum) pain score reported at one of the predefined time points 30, 60 or 90 minutes after the procedure; endpoint is proportion of patients with major pain within 90 minutes comparing LB vs non-LB groups."}

Secondary endpoints

• {"endpoint_text":"-\tPain 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.","definition_or_measurement_approach":"Pain measured on a 0-10 NRS at specified time points (within 90 minutes, at 6 hours, then daily up to day 14)."}
• {"endpoint_text":"-\tCumulative pain throughout 14 days based on the area under the curve of a pain versus time plot.","definition_or_measurement_approach":"Cumulative pain calculated as area under the curve (AUC) of pain versus time over 14 days."}
• {"endpoint_text":"-\tDuration of pain, defined as the number of days until pain scores were reported to be 0 on all following days.","definition_or_measurement_approach":"Duration measured as number of days until consecutive reports of pain score 0 on all subsequent days."}
• {"endpoint_text":"-\tDaily and overall use of analgesics up to day 14 post-procedurally registered in a patient diary (electronic or on paper).","definition_or_measurement_approach":"Analgesic use recorded daily in patient diary (electronic or paper) up to day 14; reported as daily and cumulative use."}
• {"endpoint_text":"-\tIncidence of adverse events related to LB administration (including allergic reactions to LB).","definition_or_measurement_approach":"Incidence of AEs judged related to levobupivacaine administration, including allergic reactions; collected per standard AE reporting."}
• {"endpoint_text":"-\tIncidence of serious adverse events related to LB administration (including allergic reactions to LB).","definition_or_measurement_approach":"Incidence of SAEs related to levobupivacaine administration; collected per standard SAE reporting."}
• {"endpoint_text":"-\tLength of hospital stay in days.","definition_or_measurement_approach":"Length of hospital stay measured in days."}

Netherlands

Earliest CTIS Part Ii Submission Date

22-08-2024

Latest Decision Or Authorization Date

16-01-2026

Processing Time Days

512

Number Of Sites

5

Number Of Participants

88

Primary sponsor

Full Name

Sint Antonius Ziekenhuis Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands