Ropivacaine For Post-POEM Pain Control

NCT03702647 | Completed

• 1 other identifier: DMED -2186-18
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Achalasia; Esophageal Achalasia

Keywords

Peroral Endoscopic Myotomy; Ropivacaine; Post-procedure pain control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Post-POEM pain level

  0, 0.5, 1, 2, 4 hours post-POEM procedure

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

  Assessed up to 24 hours post-POEM procedure

• Post-POEM analgesic

  0 -6 hours post-procedure

• Adverse Events

  Assessed up to 24 hours post-POEM procedure

• Fentanyl consumption

  Intra-procedure

Study Arms (2)

Ropivacaine

EXPERIMENTAL

30mL of 0.2% Ropivacaine placed in the POEM tunnel

Drug: Ropivacaine

Normal Saline

PLACEBO COMPARATOR

30mL of normal saline placed in the POEM tunnel

Drug: Normal saline

Interventions

Ropivacaine DRUG

30mL of 0.2% Ropivacaine placed in the POEM tunnel

Ropivacaine

Normal saline DRUG

30mL of normal saline placed in the POEM tunnel

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older undergoing POEM procedure
• Able to provide written informed consent
• Fluent and literate in English

You may not qualify if:

• 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

Sponsors & Collaborators

• Lawrence Charles Hookey: lead

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 5G2, Canada

Location

Related Publications (18)

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  PMID: 20800108 BACKGROUND

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  PMID: 10935657 BACKGROUND

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  PMID: 8386130 BACKGROUND

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  PMID: 9052510 BACKGROUND

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  PMID: 22947106 BACKGROUND

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  PMID: 23877351 BACKGROUND

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  PMID: 29548347 BACKGROUND

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  PMID: 8287299 BACKGROUND

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MeSH Terms

Conditions

Esophageal Achalasia

Interventions

Ropivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Robert Bechara, M.D.

  Queens University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomized by an independent research pharmacist to receive either 30mL 0.2% ropivacaine or 30mL of placebo (saline), both being clear, colorless solutions. These samples will be prepared by the research pharmacist 2-3 weeks prior to the procedure and stored until the procedure date as per pharmacy standards. On the morning of the procedure, the study solution will be taken to the operating room with the patient. During the POEM procedure, prior to closure of the mucosotomy, the study solution is instilled into the tunnel. The investigator, patient, care provider, and research coordinator will be blinded to the group assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 11, 2018
• Study Start: June 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: January 18, 2021
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)