Ft. Sam Houston, Texas 78219


Purpose:

Patients will be randomized to a placebo or study group who will receive topical lidocaine prior to EGD. Amount of medication used, recovery time, patient/endoscopist satisfaction will then be assessed.


Study summary:

The study will be a double blinded randomized placebo controlled trial Patients between 18 and 89 years old who are scheduled for EGD may be eligible to enroll in the study. Potential subjects will be sought through referral by their treating attending and fellow gastroenterologist, who will be apprised of the inclusion and exclusion criteria. Patients possibly meeting inclusive and exclusive criteria will be approached and discussed the study further with the investigators. Those expressing a desire to participate in the study will be given written informed consent prior to participation. The investigators will enroll patients into the study with a goal of at least 53 patients in each group which is the number of patients our statistician recommended to appropriately power our study. Patients who consent to enroll in the study will be randomized into 2 groups. Group 1: Swish and swallow 10ml of 2% lidocaine solution Group 2: Swish and swallow 10ml of 0.45% sodium chloride solution The patients will then undergo endoscopy for the indication identified in their clinic appointment. Following the procedure, patients will be taken to the recovery area and recovered per clinic protocol. The endoscopist will complete a satisfaction questionnaire. The day following the procedure a nurse will call to check for post-operative complications per clinic protocol. The day following, an investigator will also call to perform a patient satisfaction survey..


Criteria:

Inclusion Criteria: - EGD alone performed by staff gastroenterologist as an outpatient - Between the age of 18 and 89 - Not requiring anesthesia support or use of medications other than fentanyl and midazolam Exclusion Criteria: - Prior history of head and neck surgery - Known hypersensitivity to local anesthetics, the amide type or any components of the topical lidocaine - Patients having interventions other than polypectomy performed - Pregnant or breast feeding females - Patients with severe liver impairment - Known hypersensitivity to benzodiazepine or fentanyl


NCT ID:

NCT02620501


Primary Contact:

Principal Investigator
Adam M Tritsch, MD
Brooke Army Medical Center

Adam M Tritsch, MD
Phone: 210-916-4367
Email: adam.m.tritsch.mil@mail.mil


Backup Contact:

N/A


Location Contact:

Ft. Sam Houston, Texas 78219
United States

Adam M Tritsch, MD

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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