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

• Status: Completed
• Trial end date: 2020-06-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Advocate Health Care
• Treatments: Lidocaine

Criteria

Inclusion Criteria:

• Patients older than 18 years of age

• Patients undergoing endoscopic hemorrhoid band ligation at Advocate Christ Medical Center

Exclusion Criteria:

• Patients undergoing endoscopic hemorrhoids band ligation who are already on pain medications chronically due to other reasons

• Patients with moderate to severe renal impairment, defined as creatinine greater than 2

• Patients with hepatic dysfunction, defined as patients with signs or symptoms of liver dysfunction and/or patients with Childs Pugh Class C

• Patients with any history of arrhythmias or are currently on anti-arrhythmic medications

• Patients with any contraindications to lidocaine, including hypersensitivity to local anesthetics of the amide type or any other component within the lidocaine 2% jelly

• Patients with traumatized rectal mucosa in the area of application at the time of the procedure

• Patients who are currently pregnant