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

November 6, 2019

Overview

This clinical trial studies how a Lidocaine Hydrochloride gel enema reduces pain after endoscopic band ligation of internal hemorrhoids. The study will evaluate side effects and efficacy of the enema by recording pain following the procedure.

 

Study Information

During the band ligation procedure, patients will be randomly assigned to the treatment or control arm. Patients in the treatment arm will receive 15ml enema of Lidocaine gel and patients in the placebo arm will receive oral pain medications. Pain will be assessed at 1 hour, 24 hours, and 48 hours after the procedure by phone calls and patients will be monitored closely by nurses for 4 hours in an observation unit. Pain will be assessed with a numeric pain scale (0-10).

 

The data that will be collected for each patient includes gender, age, internal hemorrhoids grade, race, BMI, comorbid conditions, pain, and adverse side effects from the medication.

 

Before being enrolled, patients will undergo a comprehensive metabolic panel and blood count, as well as a urine pregnancy test if necessary. The researchers will exclude any patients with signs or symptoms of liver disease, renal or hepatic impairment, or any other exclusion criteria.

 

Inclusion Criteria

 

  • Ages 18+
  • Undergoing endoscopic hemorrhoid band ligation at Advocate Christ Medical Center

 

Exclusion Criteria

 

  • Undergoing endoscopic hemorrhoids band ligation and are already on pain medications chronically due to other reasons
  • Have moderate to severe renal impairment, defined as creatinine > 2
  • Have hepatic dysfunction, defined as having signs or symptoms of liver dysfunction and/or Childs Pugh Class C
  • Any history of arrhythmias or are currently on anti-arrhythmic medications
  • Any contraindications to lidocaine, including hypersensitivity to local anesthetics of the amide type or any other component within the lidocaine 2% jelly
  • Traumatized rectal mucosa in the area of application at the time of the procedure
  • Currently pregnant

 

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, United States, 60453

Contact: Charles Berkelhammer, MD    708-499-5678 charlesberkel@aol.com  

Principal Investigator: Charles Berkelhammer, MD        

Sub-Investigator: Elizabeth Brindise, DO         

 

Sponsors/Collaborators

Advocate Health Care

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