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Effect of Epinephrine on Post-polypectomy Pain

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ClinicalTrials.gov Identifier: NCT04065451
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Douglas K. Rex, Indiana University

Tracking Information
First Submitted Date  ICMJE August 15, 2019
First Posted Date  ICMJE August 22, 2019
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE January 6, 2020
Estimated Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
  • en bloc resection [ Time Frame: During the colonoscopy procedure ]
    yes or no for complete removal of the polyp en bloc
  • 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
  • quality of the mound [ Time Frame: During the colonoscopy procedure ]
    endoscopist impression of lift provided by the submucosal injection, excellent, good or inadequate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Epinephrine on Post-polypectomy Pain
Official Title  ICMJE Effect of Epinephrine on Immediate Post-polypectomy Pain in Rectal Lesions Larger Than 20 mm
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Colonic Polyp
Intervention  ICMJE Drug: Epinephrine
Epinephrine in the submucosal injection fluid
Study Arms  ICMJE
  • Experimental: Epinephrine
    Epinephrine in the submucosal injection fluid (1:200,000)
    Intervention: Drug: Epinephrine
  • No Intervention: No epinephrine
    Submucosal injection fluid without epinephrine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 20, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2020
Estimated Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Krishna Vemulapalli, MBBS 3179480117 kvemulap@iu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04065451
Other Study ID Numbers  ICMJE 1908473351
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Douglas K. Rex, Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Douglas K Rex, MD IU
PRS Account Indiana University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP