Clinical trial NCT03702647: Ropivacaine For Post-POEM Pain Control
Official title: Ropivacaine For Post-POEM Pain Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achalasia
Esophageal Achalasia
Keywords: Peroral Endoscopic Myotomy
Ropivacaine
Post-procedure pain control
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-POEM pain level
timeFrame: 6 hours post-POEM procedure
Secondary outcomes:
measure: Post-POEM pain level
timeFrame: 0, 0.5, 1, 2, 4 hours post-POEM procedure
measure: Quality of Recovery (QoR-15) score on the day of discharge
timeFrame: Assessed up to 24 hours post-POEM procedure
measure: Post-POEM analgesic
timeFrame: 0 -6 hours post-procedure
measure: Adverse Events
timeFrame: Assessed up to 24 hours post-POEM procedure
measure: Fentanyl consumption
timeFrame: Intra-procedure
measure: Repeatability of procedure
timeFrame: Assessed 24 hours post-POEM procedure
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
Study officials:
affiliation: Queens University
name: Robert Bechara, M.D.
role: PRINCIPAL_INVESTIGATOR
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