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Completed

NCT Number: NCT03702647

Ropivacaine For Post-POEM Pain Control

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 5G2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

30mL of 0.2% Ropivacaine placed in the POEM tunnel

normal saline

Drug

30mL of normal saline placed in the POEM tunnel

Primary outcomes

  1. Post-POEM pain level

    Time frame: 6 hours post-POEM procedure

    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.

Secondary outcomes

  1. Post-POEM pain level

    Time frame: 0, 0.5, 1, 2, 4 hours post-POEM procedure

    Assessing pain scores at 0, 0.5, 1, 2, 4 hours post-POEM and on discharge

  2. Quality of Recovery (QoR-15) score on the day of discharge

    Time frame: Assessed up to 24 hours post-POEM procedure

    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.

  3. Post-POEM analgesic

    Time frame: 0 -6 hours post-procedure

    The requirement of post-POEM analgesic

  4. Adverse Events

    Time frame: Assessed up to 24 hours post-POEM procedure

    Adverse events in hospital

  5. Fentanyl consumption

    Time frame: Intra-procedure

    Intraprocedural fentanyl consumption

  6. Repeatability of procedure

    Time frame: Assessed 24 hours post-POEM 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.

Sponsors and collaborators

Lead sponsor

Lawrence Charles Hookey

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Oct 11, 2018
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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