Post Operative Pain Control of POEM Procedure

Study Overview
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Brief Summary
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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.

Official Title
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Influence of Intraoperative Opioids (Oxycodone/Fentanyl) Usage on the Post-operative Pain Management of Peroral Endoscopic Myotomy (POEM)

Conditions
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Achalasia

Intervention / Treatment
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* Drug: Fentanyl
* Drug: Oxycodone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fentanyl<br>the patients use remifentanil and fentanyl as intra-operatively pain control and compare the post-operative pain condition with the oxycodone group | Drug: Fentanyl<br>* the patients use remifentanil and fentanyl as intra-operatively pain control and compare the post-operative pain condition with the oxycodone group<br>|
| Experimental: oxycodone<br>the patients use oxycodone and remifentanil as intra-operatively pain control and compare the post-operative pain condition with the fentanyl group | Drug: Oxycodone<br>* the patients use oxycodone and remifentanil as intra-operatively pain control and compare the post-operative pain condition with the fentanyl group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative pain condition | use Visual Analogue Scale/Score(0-10) to record post operative pain | 36 hours after the POEM surgery | 
| post-operative PCA usage volumn | record PCA usage volumn(ml) to see the dosage of opiods used after the surgery | 36 hours after the POEM 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 | 48 hoursafter the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chronic pain condition | use Visual Analogue Scale/Score(0-10) to evaluate the pain condition | 28 days after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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achalasia, Peroral endoscopic myotomy, post-operative pain