AchalasiaPhase 4NCT04177342
Post Operative Pain Control of POEM Procedure
A Phase 4 study testing Fentanyl and Oxycodone in people with Achalasia, run by Chen Wannan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Achalasia
- What is being tested?
- Fentanyl and Oxycodone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 30 Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Achalasia patients undergoing elective POEM surgery
- age 18-80
- BMI 18-30 kg/m2
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Achalasia
- Keywords
- achalasia, Peroral endoscopic myotomy, post-operative pain
- Medical subject headings
- Esophageal Achalasia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
the patients use remifentanil and fentanyl as intra-operatively pain control and compare the post-operative pain condition with the oxycodone group
OxycodoneDrug
the patients use oxycodone and remifentanil as intra-operatively pain control and compare the post-operative pain condition with the fentanyl group
| Study group | Role | What they receive |
|---|---|---|
| fentanyl | Active comparator | the patients use remifentanil and fentanyl as intra-operatively pain control and compare the post-operative pain condition with the oxycodone group Receives: Drug: Fentanyl |
| oxycodone | Experimental | the patients use oxycodone and remifentanil as intra-operatively pain control and compare the post-operative pain condition with the fentanyl group Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative pain condition
use Visual Analogue Scale/Score(0-10) to record post operative pain
Measured: 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
Measured: 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
Measured: 48 hoursafter the surgery
Secondary outcomes (1)
chronic pain condition
use Visual Analogue Scale/Score(0-10) to evaluate the pain condition
Measured: 28 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Wannan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Wannan, Shanghai Zhongshan Hospital
- Investigators
- Wannan Chen, MD, Principal investigator, Shanhai Zhongshan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177342
- Sponsor's protocol ID
- POEM pain control
- Status last verified
- Nov 2019
- First submitted
- 2 Apr 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Intraoperative Opioids (Oxycodone/Fentanyl) Usage on the Post-operative Pain Management of Peroral Endoscopic Myotomy (POEM)
- ClinicalTrials.gov ID
- NCT04177342
- Acronym / sponsor ID
- POEM pain control
- Conditions
- Achalasia
- Keywords
- achalasia, Peroral endoscopic myotomy, post-operative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Chen WannanUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| fentanyl | Active comparator | Drug: Fentanylthe patients use remifentanil and fentanyl as intra-operatively pain control and compare the post-operative pain condition with the oxycodone group |
| oxycodone | Experimental | Drug: Oxycodonethe patients use oxycodone and remifentanil as intra-operatively pain control and compare the post-operative pain condition with the fentanyl group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Achalasia patients undergoing elective POEM surgery
- age 18-80
- BMI 18-30 kg/m2
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanylthe patients use remifentanil and fentanyl as intra-operatively pain control and compare the post-operative pain condition with the oxycodone group | Drug | fentanyl |
| Oxycodonethe patients use oxycodone and remifentanil as intra-operatively pain control and compare the post-operative pain condition with the fentanyl group | Drug | oxycodone |
Primary outcome
post-operative pain condition
Time frame: 36 hours after the POEM surgery
use Visual Analogue Scale/Score(0-10) to record post operative pain
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
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
1 secondary outcome
chronic pain condition
Time frame: 28 days after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
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Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wannan Chen, MD principal investigator
Shanhai Zhongshan
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl and Oxycodone in people with Achalasia, run by Chen Wannan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wannan Chen, MD (8613524684181, chen.wannan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative pain condition (time frame: 36 hours after the POEM surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.