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Effect of Epinephrine on Post-polypectomy Pain

Primary Purpose

Colonic Polyp

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Epinephrine
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Polyp

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Indiana University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Epinephrine

No epinephrine

Arm Description

Epinephrine in the submucosal injection fluid (1:200,000)

Submucosal injection fluid without epinephrine

Outcomes

Primary Outcome Measures

Immediate Post-polypectomy Pain
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)
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

en Bloc Resection
Number of polyps removed en bloc (in 1 piece) vs number of polyps removed piecemeal (in more than 1 piece)
Sydney Resection Quotient
size of the polyp in mm divided by the number of pieces the polyps is removed in
Quality of the Mound
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
Number of polyps with intraprocedural bleeding during removal

Full Information

First Posted
August 15, 2019
Last Updated
September 20, 2022
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT04065451
Brief Title
Effect of Epinephrine on Post-polypectomy Pain
Official Title
Effect of Epinephrine on Immediate Post-polypectomy Pain in Colorectal Lesions Larger Than 20 mm
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
August 17, 2021 (Actual)
Study Completion Date
August 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epinephrine
Arm Type
Experimental
Arm Description
Epinephrine in the submucosal injection fluid (1:200,000)
Arm Title
No epinephrine
Arm Type
No Intervention
Arm Description
Submucosal injection fluid without epinephrine
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Intervention Description
Epinephrine in the submucosal injection fluid
Primary Outcome Measure Information:
Title
Immediate Post-polypectomy Pain
Description
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
Time Frame
30 minutes after the procedure
Title
Immediate Post Polypectomy Pain (1hour)
Description
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
Time Frame
1 hour after procedure
Secondary Outcome Measure Information:
Title
en Bloc Resection
Description
Number of polyps removed en bloc (in 1 piece) vs number of polyps removed piecemeal (in more than 1 piece)
Time Frame
During the colonoscopy procedure, an average of 47.3 minutes
Title
Sydney Resection Quotient
Description
size of the polyp in mm divided by the number of pieces the polyps is removed in
Time Frame
During the colonoscopy procedure, an average of 47.3 minutes
Title
Quality of the Mound
Description
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.
Time Frame
During the colonoscopy procedure, an average of 47.3 minutes
Title
Frequency of Immediate Bleeding
Description
Number of polyps with intraprocedural bleeding during removal
Time Frame
During the colonoscopy procedure, an average of 47.3 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas K Rex, MD
Organizational Affiliation
IU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23022496
Citation
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.
Results Reference
background
PubMed Identifier
26077453
Citation
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.
Results Reference
background
PubMed Identifier
28061339
Citation
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.
Results Reference
background
Citation
World Health Organization. Epinephrine (for use with local anaesthetics). Model Prescribing Information: Drugs Used in Anaesthesis, Geneva, 1989:33
Results Reference
background
PubMed Identifier
34896443
Citation
Rex DK, Lahr RE, Peterson MM, Vemulapalli KC. Impact of including epinephrine in the submucosal injectate for colorectal EMR on postprocedural pain: a randomized controlled trial. Gastrointest Endosc. 2022 Mar;95(3):535-539.e1. doi: 10.1016/j.gie.2021.11.043. Epub 2021 Dec 9.
Results Reference
derived

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Effect of Epinephrine on Post-polypectomy Pain

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