Effect of Epinephrine on Post-polypectomy Pain

NCT04065451 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 1908473351
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Polyp

Outcome Measures

Primary Outcomes (2)

• 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

  30 minutes after the procedure

• 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

  1 hour after procedure

Secondary Outcomes (4)

• en Bloc Resection

  During the colonoscopy procedure, an average of 47.3 minutes

• Sydney Resection Quotient

  During the colonoscopy procedure, an average of 47.3 minutes

• Quality of the Mound

  During the colonoscopy procedure, an average of 47.3 minutes

• Frequency of Immediate Bleeding

  During the colonoscopy procedure, an average of 47.3 minutes

Study Arms (2)

Epinephrine

EXPERIMENTAL

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

Drug: Epinephrine

No epinephrine

NO INTERVENTION

Submucosal injection fluid without epinephrine

Interventions

Epinephrine DRUG

Epinephrine in the submucosal injection fluid

Epinephrine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (5)

• 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.

  PMID: 23022496 BACKGROUND

• 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.

  PMID: 26077453 BACKGROUND

• 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.

  PMID: 28061339 BACKGROUND

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

  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.

  PMID: 34896443 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

* Number of patients in study was small but sample size calculation was performed prior to initiating the study. * Study conducted by single experienced endoscopist which might limit generalizability. * Blinding to the use of epinephrine proved to not be possible due to the blanching effect of epinephrine.

Results Point of Contact

• Title: Clinical Research Specialist
• Organization: Indiana University

rlahr@iu.edu

317-948-0724

Study Officials

• Douglas K Rex, MD

  IU

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 22, 2019
• Study Start: January 6, 2020
• Primary Completion: August 17, 2021
• Study Completion: August 17, 2021
• Last Updated: September 30, 2022
• Results First Posted: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)