Effect of Epinephrine on Post-polypectomy Pain

Study Overview
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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.

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

Conditions
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Colonic Polyp

Intervention / Treatment
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* Drug: Epinephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients aged 18 years and over Patients scheduled for treatment of large (≥ 20 mm) colorectal polyps Able to sign informed consent Exclusion Criteria 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epinephrine<br>Epinephrine in the submucosal injection fluid (1:200,000) | Drug: Epinephrine<br>* Epinephrine in the submucosal injection fluid<br>|
| No Intervention: No epinephrine<br>Submucosal injection fluid without epinephrine | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Frequency of Immediate Bleeding | Number of polyps with intraprocedural bleeding during removal | During the colonoscopy procedure, an average of 47.3 minutes |