Ropivacaine For Post-POEM Pain Control

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Ropivacaine For Post-POEM Pain Control

Conditions
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Achalasia, Esophageal Achalasia

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and older undergoing POEM procedure Able to provide written informed consent Fluent and literate in English Exclusion Criteria: Patients with known adverse reactions to local anesthetics and NSAIDs (GFR<50) Patients with chronic pain taking regular analgesics or narcotics (requiring daily opioid therapy > 30 mg morphine or equivalents) Patients unable to give informed consent

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients enrolled in the study will be randomized to receive either 30mL of normal saline (placebo), or 30mL of 0.2% ropivacaine in the POEM tunnel.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine<br>30mL of 0.2% Ropivacaine placed in the POEM tunnel | Drug: Ropivacaine<br>* 30mL of 0.2% Ropivacaine placed in the POEM tunnel<br>|
| Placebo Comparator: Normal Saline<br>30mL of normal saline placed in the POEM tunnel | Drug: Normal saline<br>* 30mL of normal saline placed in the POEM tunnel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-POEM pain level | To assess the effect of the intervention/placebo on pain 6-hours post-POEM as assessed via the Numeric Rating Scale (NRS): The patient will be asked to rate their pain on a scale of 0-10, 0 representing no pain, and 10 representing the worst pain they have ever felt in their life. | 6 hours post-POEM procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-POEM pain level | Assessing pain scores at 0, 0.5, 1, 2, 4 hours post-POEM and on discharge | 0, 0.5, 1, 2, 4 hours post-POEM procedure | 
| Quality of Recovery (QoR-15) score on the day of discharge | Quality of Recovery-15 score: This survey captures patient's initial post-operative health condition and their overall patient experience. The patient will be asked to rate various emotional and physical aspects of their post-operative condition on a scale of 0-10. 0 will represent an emotion or activity experienced or accomplished none of the time, and 10 will represent an emotion or activity accomplished all of the time. Scores are summed; higher scores indicate a more optimal post-operative condition. | Assessed up to 24 hours post-POEM procedure | 
| Post-POEM analgesic | The requirement of post-POEM analgesic | 0 -6 hours post-procedure | 
| Adverse Events | Adverse events in hospital | Assessed up to 24 hours post-POEM procedure | 
| Fentanyl consumption | Intraprocedural fentanyl consumption | Intra-procedure | 
| Repeatability of procedure | Patient's willingness to have the procedure done on an outpatient basis: Patients will be asked if they are willing or not willing to have the procedure done on an outpatient basis. | Assessed 24 hours post-POEM procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peroral Endoscopic Myotomy, Ropivacaine, Post-procedure pain control