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

NCT03797703 | Completed Phase 1 FDA Drug

• 1 other identifier: AHC-6999-M5000223
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemorrhoids

Outcome Measures

Primary Outcomes (1)

• Change in Pain following Procedure at 1 hour, 24 hours and 48 hours

  This effect will be measured by statistical analysis comparing the treatment groups numeric pain scale ratings (0-10) with the control groups numeric pain scale ratings (0-10).

  This information will be collected at 1 hour, 24 hours and 48 hours after the procedure.

Secondary Outcomes (1)

• Pain Medication Needs

  This will be evaluated 48 hours after the procedure.

Study Arms (2)

Treatment

EXPERIMENTAL

Patients will be randomly allocated into the treatment group. The treatment group will receive a 15 mL lidocaine gel enema rectally immediately following completion of the procedure.

Drug: Lidocaine Hydrochloride 2% gel enema

Control

NO INTERVENTION

Patients will be randomly allocated into the control group. The control group will not receive a rectal enema.

Interventions

Lidocaine Hydrochloride 2% gel enema DRUG

Insertion of Lidocaine Hydrochloride 2% gel enema rectally immediately following the procedure.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years of age
• Patients undergoing endoscopic hemorrhoid band ligation at Advocate Christ Medical Center

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

MeSH Terms

Conditions

Hemorrhoids

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Charles Berkelhammer, MD

  advocate christ medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: January 9, 2019
• Study Start: November 26, 2018
• Primary Completion: May 29, 2020
• Study Completion: June 5, 2020
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)