CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Ropivacaine +1 moredrug
Likely dose
Ropivacaine 30mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03702647
NCT03702647N/ACompleted

Ropivacaine For Post-POEM Pain Control

Lawrence Charles Hookey·interventional·Posted Oct 11, 2018·Updated Jan 26, 2021

In Brief

A clinical study evaluating Ropivacaine and Normal saline for Achalasia and Esophageal Achalasia. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 11, 2018
Enrollment StartJun 1, 2019
Primary CompletionDec 1, 2020
Study CompletionJan 18, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.7 years ago

Interventions

Ropivacainedrug

30mL of 0.2% Ropivacaine placed in the POEM tunnel

Normal salinedrug

30mL of normal saline placed in the POEM tunnel