- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04177342
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
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
- Name: Wannan Chen, MD
- Phone Number: 8613524684181
- Email: chen.wannan@zs-hospital.sh.cn
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
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Gastrointestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Pain, Postoperative
- Esophageal Achalasia
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Fentanyl
- Oxycodone
Other Study ID Numbers
- POEM pain control
Drug and device information, study documents
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
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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