Effect of Epinephrine on Post-polypectomy Pain

Phase 4

Completed

• Conditions: Colonic Polyp
• Interventions: Drug: Epinephrine

• Registration Number: NCT04065451
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-20
• Study First Posted: 2019-08-22
• Study Start: 2020-01-06
• Primary Completion: 2021-08-17
• Study Completion: 2021-08-17
• Results First Submitted: 2022-06-23
• Status Verified: 2022-09
• Results First Submitted QC: 2022-09-20
• Last Update Submitted: 2022-09-20
• Results First Posted: 2022-09-30
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Immediate Post-polypectomy Pain	30 minutes after the procedure	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)	1 hour after procedure	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

Name	Time	Method
Sydney Resection Quotient	During the colonoscopy procedure, an average of 47.3 minutes	size of the polyp in mm divided by the number of pieces the polyps is removed in
Frequency of Immediate Bleeding	During the colonoscopy procedure, an average of 47.3 minutes	Number of polyps with intraprocedural bleeding during removal
en Bloc Resection	During the colonoscopy procedure, an average of 47.3 minutes	Number of polyps removed en bloc (in 1 piece) vs number of polyps removed piecemeal (in more than 1 piece)
Quality of the Mound	During the colonoscopy procedure, an average of 47.3 minutes	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.

Trial Locations

Locations (1)

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States