Clinical trial NCT04065451: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonic Polyp
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Immediate Post-polypectomy Pain
timeFrame: 30 minutes after the procedure
measure: Immediate Post Polypectomy Pain (1hour)
timeFrame: 1 hour after procedure
Secondary outcomes:
measure: en Bloc Resection
timeFrame: During the colonoscopy procedure, an average of 47.3 minutes
measure: Sydney Resection Quotient
timeFrame: During the colonoscopy procedure, an average of 47.3 minutes
measure: Quality of the Mound
timeFrame: During the colonoscopy procedure, an average of 47.3 minutes
measure: Frequency of Immediate Bleeding
timeFrame: During the colonoscopy procedure, an average of 47.3 minutes
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: IU
name: Douglas K Rex, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: World Health Organization. Epinephrine (for use with local anaesthetics). Model Prescribing Information: Drugs Used in Anaesthesis, Geneva, 1989:33
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.