Effect of Epinephrine on Post-polypectomy Pain

NCT ID: NCT04065451

Last Updated: 2022-09-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2021-08-17

Brief Summary

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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

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Conditions

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Colonic Polyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Epinephrine

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

Group Type EXPERIMENTAL

Epinephrine

Intervention Type DRUG

Epinephrine in the submucosal injection fluid

No epinephrine

Submucosal injection fluid without epinephrine

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Epinephrine

Epinephrine in the submucosal injection fluid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Douglas K. Rex

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Douglas K Rex, MD

Role: PRINCIPAL_INVESTIGATOR

IU

Locations

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Indiana University Hospital

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23022496 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26077453 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28061339 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type DERIVED
PMID: 34896443 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1908473351

Identifier Type: -

Identifier Source: org_study_id

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