drugset / Trial / NCT03797703

Efficacy of Lidocaine Gel Enema After Endoscopic Hemorrhoid Band Ligation for Relief of Post Procedural Pain

NCT03797703

Phase 1 Completed 75 enrolled Wake Forest University Health Sciences
RandomizedParallel-groupTriple-blindSupportive care

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.

Timeline

Start
2018-11-26
Primary completion
2020-05-29
Completion
2020-06-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine Other / unclassified 2 % Rectal
Subject Lidocaine Other / unclassified 15 ml Rectal

Indications