Ropivacaine For Post-POEM Pain Control

January 25, 2021 updated by: Lawrence Charles Hookey
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 5G2
        • Kingston Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Ropivacaine
30mL of 0.2% Ropivacaine placed in the POEM tunnel
Drug: Ropivacaine
30mL of 0.2% Ropivacaine placed in the POEM tunnel
PLACEBO_COMPARATOR: Normal Saline
30mL of normal saline placed in the POEM tunnel
Drug: Normal saline
30mL of normal saline placed in the POEM tunnel

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 hours post-POEM procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
0, 0.5, 1, 2, 4 hours post-POEM procedure
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.
Assessed up to 24 hours post-POEM procedure
Post-POEM analgesic
Time Frame: 0 -6 hours post-procedure
The requirement of post-POEM analgesic
0 -6 hours post-procedure
Adverse Events
Time Frame: Assessed up to 24 hours post-POEM procedure
Adverse events in hospital
Assessed up to 24 hours post-POEM procedure
Fentanyl consumption
Time Frame: Intra-procedure
Intraprocedural fentanyl consumption
Intra-procedure
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.
Assessed 24 hours post-POEM procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lawrence Charles Hookey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Bechara, M.D., Queens University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 18, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DMED -2186-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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