Post Operative Pain Control of POEM Procedure

Phase 4

• Conditions: Achalasia
• Interventions: Drug: Oxycodone; Drug: Fentanyl

• Registration Number: NCT04177342
• Lead Sponsor: Chen Wannan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-02
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-22
• Last Update Submitted: 2019-11-22
• Study First Posted: 2019-11-26
• Last Update Posted: 2019-11-26
• Study Start: 2020-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 196

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oxycodone	Oxycodone	the patients use oxycodone and remifentanil as intra-operatively pain control and compare the post-operative pain condition with the fentanyl group
fentanyl	Fentanyl	the patients use remifentanil and fentanyl as intra-operatively pain control and compare the post-operative pain condition with the oxycodone group

Primary Outcome Measures

Name	Time	Method
post-operative pain condition	36 hours after the POEM surgery	use Visual Analogue Scale/Score(0-10) to record post operative pain
post-operative sleep quality	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
post-operative PCA usage volumn	36 hours after the POEM surgery	record PCA usage volumn(ml) to see the dosage of opiods used after the surgery

Secondary Outcome Measures

Name	Time	Method
chronic pain condition	28 days after discharge	use Visual Analogue Scale/Score(0-10) to evaluate the pain condition