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OpenTrials
Completed

NCT Number: NCT04065451

Effect of Epinephrine on Post-polypectomy Pain

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.

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Key information

Conditions

Colonic Polyp Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 years and over
  • Patients scheduled for treatment of large (≥ 20 mm) colorectal polyps
  • Able to sign informed consent

Exclusion criteria

  • Patients previously enrolled in the study
  • Pedunculated polyps
  • Polyps not amenable to endoscopic resection
  • Patients allergic or sensitive to epinephrine
  • 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.
  • Patients electing anesthesia other than monitored anesthesia care with propofol (MAC) for colonoscopy

Treatment and study plan

Epinephrine

Drug

Epinephrine in the submucosal injection fluid

Primary outcomes

  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

  2. 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 outcomes

  1. 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)

  2. 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

  3. 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.

  4. Frequency of Immediate Bleeding

    Time frame: During the colonoscopy procedure, an average of 47.3 minutes

    Number of polyps with intraprocedural bleeding during removal

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Effect of Epinephrine on Immediate Post-polypectomy Pain in Colorectal Lesions Larger Than 20 mm

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 22, 2019
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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