Post Operative Pain Control of POEM Procedure

November 22, 2019 updated by: Chen Wannan

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

196

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-operative pain condition
Time Frame: 36 hours after the POEM surgery
use Visual Analogue Scale/Score(0-10) to record post operative pain
36 hours after the POEM surgery
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
36 hours after the POEM surgery
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
48 hoursafter the surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Wannan Chen, MD, Shanhai Zhongshan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

June 30, 2021

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

November 22, 2019

First Posted (ACTUAL)

November 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 26, 2019

Last Update Submitted That Met QC Criteria

November 22, 2019

Last Verified

November 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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