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Post Operative Pain Control of POEM Procedure

Primary Purpose

Achalasia

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fentanyl
Oxycodone
Sponsored by
Chen Wannan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achalasia focused on measuring achalasia, Peroral endoscopic myotomy, post-operative pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Achalasia patients undergoing elective POEM surgery
  • age 18-80
  • BMI 18-30 kg/m2

Exclusion Criteria:

  • Patient refusal
  • ASA≥ 3
  • abnormality of liver and kidney function in patients
  • patients with mental disorder, language disorder, and other patients who can not cooperate with and complete the follow-up and questionnaire pre- and post- operatively
  • patients (including propanotamo, propofol, lidocaine, and other drugs) against drug taboos in the anesthetic scheme
  • patients with chronic pain before operation with analgesic drugs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    fentanyl

    oxycodone

    Arm Description

    the patients use remifentanil and fentanyl as intra-operatively pain control and compare the post-operative pain condition with the oxycodone group

    the patients use oxycodone and remifentanil as intra-operatively pain control and compare the post-operative pain condition with the fentanyl group

    Outcomes

    Primary Outcome Measures

    post-operative pain condition
    use Visual Analogue Scale/Score(0-10) to record post operative pain
    post-operative PCA usage volumn
    record PCA usage volumn(ml) to see the dosage of opiods used after the surgery
    post-operative sleep quality
    Postoperative sleep quality was investigated with a self-reported sleep questionnaire including 6 yes/no questions(0-6) with full score 6 represented the worst sleep

    Secondary Outcome Measures

    chronic pain condition
    use Visual Analogue Scale/Score(0-10) to evaluate the pain condition

    Full Information

    First Posted
    April 2, 2019
    Last Updated
    November 22, 2019
    Sponsor
    Chen Wannan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04177342
    Brief Title
    Post Operative Pain Control of POEM Procedure
    Official Title
    Influence of Intraoperative Opioids (Oxycodone/Fentanyl) Usage on the Post-operative Pain Management of Peroral Endoscopic Myotomy (POEM)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    June 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Chen Wannan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    Peroral endoscopic myotomy (POEM) is a minimally invasive treatment for esophageal achalasia with a natural orifice transluminal endoscopic procedure and far less invasive than the standard surgical or laparoscopic Heller myotomy (LHM). Less is known about the postoperative pain after POEM and the minor surgery trauma, short length of stay may lead to underestimation of postoperative pain control. We tend to observe the pain status after the POEM surgery under the empirical treatment in our center, and find a proper intra-operative way of pain control to solve the post-operative pain and seek the possible influence factors of postoperative pain.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Achalasia
    Keywords
    achalasia, Peroral endoscopic myotomy, post-operative pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    patients will be devided randomly into two groups. One group will be given oxycodone and the other will be given fentanyl during the POEM procedure. Post procedure pain condition will be recorded.
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    196 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    fentanyl
    Arm Type
    Active Comparator
    Arm Description
    the patients use remifentanil and fentanyl as intra-operatively pain control and compare the post-operative pain condition with the oxycodone group
    Arm Title
    oxycodone
    Arm Type
    Experimental
    Arm Description
    the patients use oxycodone and remifentanil as intra-operatively pain control and compare the post-operative pain condition with the fentanyl group
    Intervention Type
    Drug
    Intervention Name(s)
    Fentanyl
    Intervention Description
    the patients use remifentanil and fentanyl as intra-operatively pain control and compare the post-operative pain condition with the oxycodone group
    Intervention Type
    Drug
    Intervention Name(s)
    Oxycodone
    Intervention Description
    the patients use oxycodone and remifentanil as intra-operatively pain control and compare the post-operative pain condition with the fentanyl group
    Primary Outcome Measure Information:
    Title
    post-operative pain condition
    Description
    use Visual Analogue Scale/Score(0-10) to record post operative pain
    Time Frame
    36 hours after the POEM surgery
    Title
    post-operative PCA usage volumn
    Description
    record PCA usage volumn(ml) to see the dosage of opiods used after the surgery
    Time Frame
    36 hours after the POEM surgery
    Title
    post-operative sleep quality
    Description
    Postoperative sleep quality was investigated with a self-reported sleep questionnaire including 6 yes/no questions(0-6) with full score 6 represented the worst sleep
    Time Frame
    48 hoursafter the surgery
    Secondary Outcome Measure Information:
    Title
    chronic pain condition
    Description
    use Visual Analogue Scale/Score(0-10) to evaluate the pain condition
    Time Frame
    28 days after discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Achalasia patients undergoing elective POEM surgery age 18-80 BMI 18-30 kg/m2 Exclusion Criteria: Patient refusal ASA≥ 3 abnormality of liver and kidney function in patients patients with mental disorder, language disorder, and other patients who can not cooperate with and complete the follow-up and questionnaire pre- and post- operatively patients (including propanotamo, propofol, lidocaine, and other drugs) against drug taboos in the anesthetic scheme patients with chronic pain before operation with analgesic drugs
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wannan Chen, MD
    Phone
    8613524684181
    Email
    chen.wannan@zs-hospital.sh.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wannan Chen, MD
    Organizational Affiliation
    Shanhai Zhongshan
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Post Operative Pain Control of POEM Procedure

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