Post Operative Pain Control of POEM Procedure

Sponsor

Chen Wannan (Other)

Overall Status

Unknown status

CT.gov ID

NCT04177342

Collaborator

(none)

196

Enrollment

Arms

17.9

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Achalasia	Drug: Fentanyl Drug: Oxycodone	Phase 4

Study Design

Study Type:

Interventional

Anticipated 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.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)

Anticipated Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Jun 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

post-operative pain condition [36 hours after the POEM surgery]
use Visual Analogue Scale/Score(0-10) to record post operative pain
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
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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