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Effect of Epinephrine on Post-polypectomy Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04065451
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : January 22, 2020
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 Rectal Lesions Larger Than 20 mm
Actual Study Start Date : January 6, 2020
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria

  1. Patients aged 18 years and over
  2. Patients scheduled for treatment of large (≥ 20 mm) rectal 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
  4. Patients allergic or sensitive to epinephrine
  5. Patients with coronary artery disease who have had a myocardial infarction in the past year, or had coronary stenting in the past year, or had angina in the past year.
  6. Patients electing anesthesia other than monitored anesthesia care with propofol (MAC) for colonoscopy

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 identifier (NCT number): NCT04065451

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Contact: Krishna Vemulapalli, MBBS 3179480117

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United States, Indiana
Indiana University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Douglas Rex, MD    317-948-8741      
Contact: Krishna Vemulapalli, MBBS    3179482031      
Sponsors and Collaborators
Indiana University
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Principal Investigator: Douglas K Rex, MD IU
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Responsible Party: Douglas K. Rex, Professor of Medicine, Indiana University Identifier: NCT04065451    
Other Study ID Numbers: 1908473351
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
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
Pathological Conditions, Anatomical
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
Vasoconstrictor Agents