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NCT03797703 · ClinicalTrials.gov registry record · Phase 1
Efficacy of Lidocaine Gel Enema After Endoscopic Hemorrhoid Band Ligation for Relief of Post Procedural Pain
A Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT03797703 is a Phase 1 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 75 participants.
The verdict
NCT03797703, a Phase 1 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
This is a prospective study to assess the utility of Lidocaine Hydrochloride 2% gel enema (Hi-Tech Pharmacal Co., Inc.) in reducing post-procedural pain after endoscopic band ligation of internal hemorrhoids. Briefly, patients will be consented prior to entry into the study. During the endoscopic band ligation procedure, patients will be blindly placed into the treatment arm or control arm. The treatment arm will receive 15 ml enema of lidocaine gel immediately upon cessation of the procedure. In the placebo arm, oral pain medications will be provided. Researchers will assess pain following the procedure at 1 hour, 24 hours and 48 hours via telephone call. Another telephone call will be performed at 72 to 96 hours to assess any side effects of the medication.
Interventions
- DRUG Lidocaine Hydrochloride 2% gel enema
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2018-11-26 |
| Est. Completion | 2020-06-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03797703
The ClinicalTrials.gov registry entry for NCT03797703 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lidocaine Hydrochloride 2% gel enema is the first listed.
NCT03797703 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03797703 about?
NCT03797703 is a clinical study titled "Efficacy of Lidocaine Gel Enema After Endoscopic Hemorrhoid Band Ligation for Relief of Post Procedural Pain". This is a prospective study to assess the utility of Lidocaine Hydrochloride 2% gel enema (Hi-Tech Pharmacal Co., Inc.) in reducing post-procedural pain after endoscopic band ligation of internal hemorrhoids. Briefly, patients will be consented prior to entry into the study. During the endoscopic ba...
What is the current status of trial NCT03797703?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2018-11-26. Estimated completion is 2020-06-05.
What interventions are being tested in trial NCT03797703?
The interventions under investigation include: Lidocaine Hydrochloride 2% gel enema (DRUG).
Who is sponsoring clinical trial NCT03797703?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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