drugset / Trial / NCT03702647

Ropivacaine For Post-POEM Pain Control

NCT03702647 ↗

Completed 20 enrolled Lawrence Charles Hookey
RandomizedParallel-groupQuadruple-blindOther

Summary

POEM (Peroral Endoscopic Myotomy) is an endoscopic procedure most commonly used to treat achalasia. Achalasia is a disorder resulting from the inability of esophageal muscles to relax.The POEM procedure, performed under general anesthesia, involves inserting an endoscope into the esophagus where a specialized knife is able to cut a new pathway through the esophageal tissue. The knife is then used to incise, and therefore loosen, tight muscles within the esophagus, lower esophageal sphincter, and the upper region of the stomach that are responsible for the symptoms.This study seeks to improve patient's post-operative pain levels by placing ropivacaine (a local anesthetic) into the newly cut pathway that is created in the POEM procedure. It is hypothesized that the topical irrigation of the POEM tunnel with ropivacaine will result in decreased pain scores and a decreased need for additional pain medications.

Timeline

Start
2019-06-01
Primary completion
2020-12-01
Completion
2021-01-18

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Ropivacaine Other / unclassified 0.2 % Topical
Subject Ropivacaine Other / unclassified 30 ml Topical

Indications