Effect of Epinephrine on Post-polypectomy Pain

September 20, 2022 updated by: Douglas K. Rex, Indiana University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 minutes after the procedure
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
1 hour after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
During the colonoscopy procedure, an average of 47.3 minutes
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
During the colonoscopy procedure, an average of 47.3 minutes
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.
During the colonoscopy procedure, an average of 47.3 minutes
Frequency of Immediate Bleeding
Time Frame: During the colonoscopy procedure, an average of 47.3 minutes
Number of polyps with intraprocedural bleeding during removal
During the colonoscopy procedure, an average of 47.3 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Douglas K Rex, MD, IU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2020

Primary Completion (Actual)

August 17, 2021

Study Completion (Actual)

August 17, 2021

Study Registration Dates

First Submitted

August 15, 2019

First Submitted That Met QC Criteria

August 20, 2019

First Posted (Actual)

August 22, 2019

Study Record Updates

Last Update Posted (Actual)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 20, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1908473351

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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