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Post Operative Pain Control of POEM Procedure

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ClinicalTrials.gov Identifier: NCT04177342
Recruitment Status : Not yet recruiting
First Posted : November 26, 2019
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Chen Wannan, Shanghai Zhongshan Hospital

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.

Condition or disease Intervention/treatment Phase
Achalasia Drug: Fentanyl Drug: Oxycodone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Influence of Intraoperative Opioids (Oxycodone/Fentanyl) Usage on the Post-operative Pain Management of Peroral Endoscopic Myotomy (POEM)
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021


Arm Intervention/treatment
Active Comparator: fentanyl
the patients use remifentanil and fentanyl as intra-operatively pain control and compare the post-operative pain condition with the oxycodone group
Drug: Fentanyl
the patients use remifentanil and fentanyl as intra-operatively pain control and compare the post-operative pain condition with the oxycodone group

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




Primary Outcome Measures :
  1. post-operative pain condition [ Time Frame: 36 hours after the POEM surgery ]
    use Visual Analogue Scale/Score(0-10) to record post operative pain

  2. post-operative PCA usage volumn [ Time Frame: 36 hours after the POEM surgery ]
    record PCA usage volumn(ml) to see the dosage of opiods used after the surgery

  3. post-operative sleep quality [ Time Frame: 48 hoursafter the surgery ]
    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 :
  1. chronic pain condition [ Time Frame: 28 days after discharge ]
    use Visual Analogue Scale/Score(0-10) to evaluate the pain condition



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04177342


Contacts
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Contact: Wannan Chen, MD 8613524684181 chen.wannan@zs-hospital.sh.cn

Sponsors and Collaborators
Chen Wannan
Investigators
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Principal Investigator: Wannan Chen, MD Shanhai Zhongshan
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Responsible Party: Chen Wannan, Principal Investigator, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT04177342    
Other Study ID Numbers: POEM pain control
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019

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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
Keywords provided by Chen Wannan, Shanghai Zhongshan Hospital:
achalasia
Peroral endoscopic myotomy
post-operative pain
Additional relevant MeSH terms:
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Esophageal Achalasia
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Fentanyl
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics