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Effect of Epinephrine on Post-polypectomy Pain

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ClinicalTrials.gov Identifier: NCT04065451
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Douglas K. Rex, Indiana University

Brief Summary:
Epinephrine is widely used in endoscopic mucosal resection of large polyps to prevent post-polypectomy bleeding. No previous studies looked at increase in immediate post-polypectomy pain with the use of epinephrine.

Condition or disease Intervention/treatment Phase
Colonic Polyp Drug: Epinephrine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Epinephrine on Immediate Post-polypectomy Pain in Recto-sigmoid Lesions Larger Than 20 mm
Estimated Study Start Date : September 15, 2019
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2020


Arm Intervention/treatment
Experimental: Epinephrine
Epinephrine in the submucosal injection fluid (1:200,000)
Drug: Epinephrine
Epinephrine in the submucosal injection fluid

No Intervention: No epinephrine
Submucosal injection fluid without epinephrine



Primary Outcome Measures :
  1. Immediate post-polypectomy pain [ Time Frame: 30 minutes after the procedure ]
    Pain related by the participant on a 0-100 visual analog scale; patients will be asked to mark their pain level on a straight vertical line 100 mm long and this point will be measured with a ruler for pain score. Possible values are zero- indicating no pain at all to 100-indicating worst imaginable pain


Secondary Outcome Measures :
  1. en bloc resection [ Time Frame: During the colonoscopy procedure ]
    yes or no for complete removal of the polyp en bloc

  2. sydney resection quotient [ Time Frame: During the colonoscopy procedure ]
    size of the polyp in mm divided by the number of pieces the polyps is removed in

  3. quality of the mound [ Time Frame: During the colonoscopy procedure ]
    endoscopist impression of lift provided by the submucosal injection, excellent, good or inadequate



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients aged 18 years and over
  2. Patients scheduled for treatment of recto-sigmoid large polyps
  3. Able to sign informed consent

Exclusion Criteria:

  1. Patients previously enrolled in the study
  2. Pedunculated polyps
  3. Polyps not amenable to endoscopic resection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065451


Locations
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United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University

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Responsible Party: Douglas K. Rex, Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT04065451     History of Changes
Other Study ID Numbers: 1908473351
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents