Effect of Epinephrine on Post-polypectomy Pain

Colonic Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04065451
• Other study ID #: 1908473351
• Status: Completed
• Phase: Phase 4
• Start date: January 6, 2020
• Est. completion date: August 17, 2021

Study information

• Verified date: September 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 17, 2021
• Est. primary completion date: August 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps

Intervention

Drug:
• Epinephrine
Epinephrine in the submucosal injection fluid

Locations

Country	Name	City	State
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	en Bloc Resection	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
Secondary	Sydney Resection Quotient	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
Secondary	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.	During the colonoscopy procedure, an average of 47.3 minutes
Secondary	Frequency of Immediate Bleeding	Number of polyps with intraprocedural bleeding during removal	During the colonoscopy procedure, an average of 47.3 minutes