Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. Consequently, patients experience difficulty swallowing, reflux, and weight loss. Treatment options for achalasia are generally divided into 2 categories: A) treatment with medication, or B) treatment via a procedure. Medical treatment is generally reserved for patients to unwell to undergo procedures as the efficacy is low. Additionally, patients tend to experience many side-effects. There are also procedural options used to treat achalasia which include surgical myotomy and POEM. The POEM procedure is advantageous because it is less invasive, but is at least as equally effective for symptomatic relief when compared to the surgical myotomy. 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. At the conclusion of the procedure, clips are placed in the esophagus to close the incision. Currently, patients are given intravenous ketorolac, oral viscous lidocaine and narcotic analgesics as needed to manage post-operative pain. This study, however, 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. Patients consented to participate in the study will be randomized to receive either ropivacaine (intervention group) or saline (control group). Pain will be assessed at 0.5, 1, 2, 4, and 6 hours post-admission to the recovery unit using validated pain scales. Additionally, the Quality of Recovery (QoR-15) patient survey, will be completed prior to discharge. This measure will capture the patient's initial post-operative health condition and help capture the overall patient experience. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03702647
Study type Interventional
Source Queen's University
Contact
Status Completed
Phase N/A
Start date June 1, 2019
Completion date January 18, 2021

See also
  Status Clinical Trial Phase
Completed NCT01399476 - Endoscopic Myotomy of the Lower Esophageal Sphincter for Achalasia N/A
Recruiting NCT05326113 - The Effect of Physiotherapy on Post POEM Reflux N/A
Recruiting NCT06044155 - redoPOEM : Failure of a First POEM
Recruiting NCT02989883 - Clinical Outcomes of Peroral Endoscopic Myotomy N/A
Terminated NCT02606578 - Achalasia Patient Reported Outcomes
Recruiting NCT01793922 - POEM Trial: Multi-center Study Comparing Endoscopic Pneumodilation and Per Oral Endoscopic Myotomy (POEM) N/A
Recruiting NCT01302288 - Endolumenal Partial Myotomy for the Treatment of Esophageal Achalasia Phase 2
Terminated NCT03875365 - Institutional Outcome Data From Per-oral Plication of the Esophagus
Enrolling by invitation NCT02770859 - Per-Oral Endoscopic Myotomy (POEM) for the Treatment of Achalasia, Database Repository
Recruiting NCT05905016 - Prospective Evaluation of the Clinical Utility of Peroral Endoscopic Myotomy for Gastrointestinal Motility Disorders
Completed NCT01692106 - A Clinical Study of Per Oral Endoscopic Myotomy (POEM) in Patients Suffering From Achalasia N/A
Completed NCT01405469 - Endoscopic Peroral Myotomy for Treatment of Achalasia N/A
Completed NCT01402518 - Per-Oral Endoscopic Myotomy
Not yet recruiting NCT00790465 - Efficacy of Dark Chocolate in Achalasia Patients Phase 1/Phase 2
Recruiting NCT01799967 - Minimally Invasive Surgery of the Gastro-esophageal Junction
Terminated NCT00604942 - vMII for Measurement of Oesophageal Bolus Transport and Reflux N/A
Recruiting NCT06405412 - Effects of Malnutrition on Respiratory and Renal Functions in Patients Undergoing Peroral Endoscopic Myotomy (POEM) N/A
Not yet recruiting NCT06042127 - POEM-F for Achalasia International Study N/A
Completed NCT04752670 - ConMed Beamer Study
Completed NCT02314741 - Peroral Endoscopic Myotomy (POEM) for Esophageal Motility N/A