Visible esophageal lesions ((pre)cancerous)
Conditions
Brief summary
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.
Detailed description
- 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)., - Incidence of adverse events related to LB administration (including allergic reactions to LB)., - Incidence of serious adverse events related to LB administration (including allergic reactions to LB)., - Length of hospital stay in days.
Interventions
DRUGoplossing voor injectie
DRUG5 mg/ml
Sponsors
Sint Antonius Ziekenhuis Stichting
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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)., - Incidence of adverse events related to LB administration (including allergic reactions to LB)., - Incidence of serious adverse events related to LB administration (including allergic reactions to LB)., - Length of hospital stay in days. | — |
Countries
Netherlands
Outcome results
None listed