Achalasia Clinical Trial
Official title:
Ropivacaine For Post-POEM Pain Control
Verified date | January 2021 |
Source | Queen's University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 18, 2021 |
Est. primary completion date | December 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Kingston Health Sciences Centre | Kingston | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawrence Charles Hookey |
Canada,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Post-POEM analgesic | The requirement of post-POEM analgesic | 0 -6 hours post-procedure | |
Secondary | Adverse Events | Adverse events in hospital | Assessed up to 24 hours post-POEM procedure | |
Secondary | Fentanyl consumption | Intraprocedural fentanyl consumption | Intra-procedure | |
Secondary | 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 |
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