Effect of Epinephrine on Post-polypectomy Pain

Overview

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.

Full Title of Study: “Effect of Epinephrine on Immediate Post-polypectomy Pain in Colorectal Lesions Larger Than 20 mm”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 17, 2021

Interventions

  • Drug: Epinephrine
    • Epinephrine in the submucosal injection fluid

Arms, Groups and Cohorts

  • Experimental: Epinephrine
    • Epinephrine in the submucosal injection fluid (1:200,000)
  • No Intervention: No epinephrine
    • Submucosal injection fluid without epinephrine

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • Immediate Post Polypectomy Pain (1hour)
    • Time Frame: 1 hour after 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 Measures

  • en Bloc Resection
    • Time Frame: During the colonoscopy procedure, an average of 47.3 minutes
    • Number of polyps removed en bloc (in 1 piece) vs number of polyps removed piecemeal (in more than 1 piece)
  • Sydney Resection Quotient
    • Time Frame: During the colonoscopy procedure, an average of 47.3 minutes
    • 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, an average of 47.3 minutes
    • Endoscopist impression of lift provided by the submucosal injection: excellent/adequate or insufficient. Excellent is the best rating and insufficient is the worst rating on this scale.
  • Frequency of Immediate Bleeding
    • Time Frame: During the colonoscopy procedure, an average of 47.3 minutes
    • Number of polyps with intraprocedural bleeding during removal

Participating in This Clinical Trial

Inclusion Criteria 1. Patients aged 18 years and over 2. Patients scheduled for treatment of large (≥ 20 mm) colorectal 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Indiana University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Douglas K. Rex, Professor of Medicine – Indiana University
  • Overall Official(s)
    • Douglas K Rex, MD, Principal Investigator, IU

References

Pohl H, Srivastava A, Bensen SP, Anderson P, Rothstein RI, Gordon SR, Levy LC, Toor A, Mackenzie TA, Rosch T, Robertson DJ. Incomplete polyp resection during colonoscopy-results of the complete adenoma resection (CARE) study. Gastroenterology. 2013 Jan;144(1):74-80.e1. doi: 10.1053/j.gastro.2012.09.043. Epub 2012 Sep 25. Erratum In: Gastroenterology. 2021 Oct;161(4):1347.

ASGE Technology Committee; Hwang JH, Konda V, Abu Dayyeh BK, Chauhan SS, Enestvedt BK, Fujii-Lau LL, Komanduri S, Maple JT, Murad FM, Pannala R, Thosani NC, Banerjee S. Endoscopic mucosal resection. Gastrointest Endosc. 2015 Aug;82(2):215-26. doi: 10.1016/j.gie.2015.05.001. Epub 2015 Jun 12.

Klein A, Bourke MJ. How to Perform High-Quality Endoscopic Mucosal Resection During Colonoscopy. Gastroenterology. 2017 Feb;152(3):466-471. doi: 10.1053/j.gastro.2016.12.029. Epub 2017 Jan 3. No abstract available.

World Health Organization. Epinephrine (for use with local anaesthetics). Model Prescribing Information: Drugs Used in Anaesthesis, Geneva, 1989:33

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