Status:
COMPLETED
Efficacy of Lidocaine Gel Enema After Endoscopic Hemorrhoid Band Ligation for Relief of Post Procedural Pain
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Hemorrhoids
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 hemo...
Detailed Description
This is a prospective single center study to evaluate side effects and efficacy of a lidocaine jelly 2% enema following endoscopic hemorrhoid band ligation. The investigators will administer a single ...
Eligibility Criteria
Inclusion
- Patients older than 18 years of age
- Patients undergoing endoscopic hemorrhoid band ligation at Advocate Christ Medical Center
Exclusion
- 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
Key Trial Info
Start Date :
November 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2020
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03797703
Start Date
November 26 2018
End Date
June 5 2020
Last Update
October 4 2024
Active Locations (1)
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1
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453