Esophageal CancerPhase 2/3NCT05504265
Perioperative Analgesia Modes in Minimally Invasive Esophagectomy
A Phase 2/3 study testing Preemptive flurbiprofen axetil and Postoperative flurbiprofen axetil in people with Esophageal Cancer and Perioperative Analgesia, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study was designed to compare analgesic efficacy and safety of different perioperative analgesic modes in minimally invasive esophagectomy for esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer, Perioperative Analgesia, NSAIDs
- What is being tested?
- Preemptive flurbiprofen axetil and Postoperative flurbiprofen axetil
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2022to 20 Dec 2025
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years;
- Patients underwent laparoscopic and thoracoscopic or robotic-assisted minimally invasive esophagectomy ;
- Informed consent.
Who cannot join
- Has a history of cholecystitis or urolithiasis within 3 months;
- Has a history of atherothrombosis (peripheral arterial disease), stroke, myocardial infarction;
- With lung diseases, such as pneumonia, atelectasis, emphysema, pulmonary bullae, etc;
- Preoperative cardiac function grade ≥ III or coronary artery stenosis;
- Preoperative indwelling of a thoracic drainage tube;
- Long-term heavy drinker(heavy drinking was defined as follows: for men, consuming more than 4 drinks on any day or more than 14 drinks per week; For women, consuming more than 3 drinks on any day or more than 7 drinks per week);
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- Opioid-tolerant patients(defined as those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid);
- With painful skin complications, such as rashes and blisters;
- Conversion to open surgery;
- The postoperative ventilation function was limited, or the duration of endotracheal intubation was more than 24h.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Yin Li, MD, 861087788052, liyin@cicams.ac.cn
About this study
Official title: Comparison of Efficacy and Safety of Different Analgesic Modes in Minimally Invasive Esophagectomy for Esophageal Cancer
This study was designed to compare analgesic efficacy and safety of different perioperative analgesic modes in minimally invasive esophagectomy for esophageal cancer.
- Being tested
- Preemptive flurbiprofen axetil, Postoperative flurbiprofen axetil, Patient-controlled analgesia pump
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preemptive flurbiprofen axetilDrug
50mg once，30min before induction anesthesia
Postoperative flurbiprofen axetilDrug
50mg bid
Patient-controlled analgesia pumpDevice
Sufentanil 2.5 μg/kg+ondansetron 8mg, prepared to 100ml normal saline; background dose: 2 ml/h, single press analgesic pump injection volume: 0.5 ml, locking time: 15 min.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative NSAIDs | Other | Not described Receives: Drug: Postoperative flurbiprofen axetil |
| Preemptive analgesia followed by Postoperative NSAIDs | Experimental | Not described Receives: Drug: Preemptive flurbiprofen axetil; Drug: Postoperative flurbiprofen axetil |
| Postoperative patient-controlled analgesia pump | Experimental | Not described Receives: Device: Patient-controlled analgesia pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score
In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.
Measured: 4 hours after surgery
Postoperative pain score
In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.
Measured: 12 hours after surgery
Postoperative pain score
In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.
Measured: 24 hours after surgery
Postoperative pain score
In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.
Measured: 36 hours after surgery
Postoperative pain score
In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.
Measured: 48 hours after surgery
Postoperative pain score
In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.
Measured: 60 hours after surgery
Postoperative pain score
In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.
Measured: 72 hours after surgery
Secondary outcomes (11)
Time to first postoperative flatus
Time from the end of surgery to the first flatus.
Measured: Up to 14 days after surgery
Time to first postoperative defaecation
Time from the end of surgery to the first defaecation.
Measured: Up to 14 days after surgery
Abdominal distension score
Abdominal distension was measured using a scoring system, '0' is the minimum value that indicates no abdominal distension, while '10' is the maximum value that defines the most severe abdominal distension.
Measured: 24 hours after surgery
Abdominal distension score
Abdominal distension was measured using a scoring system, '0' is the minimum value that indicates no abdominal distension, while '10' is the maximum value that defines the most severe abdominal distension.
Measured: 48 hours after surgery
Abdominal distension score
Abdominal distension was measured using a scoring system, '0' is the minimum value that indicates no abdominal distension, while '10' is the maximum value that defines the most severe abdominal distension.
Measured: 72 hours after surgery
Side effects related to opioids
Nausea and vomiting were measured using a scoring system(0 = no nausea, 1 = only nausea, 2 = both nausea and vomiting).
Measured: 24 hours after surgery
Side effects related to opioids
Nausea and vomiting were measured using a scoring system(0 = no nausea, 1 = only nausea, 2 = both nausea and vomiting).
Measured: 48 hours after surgery
Side effects related to opioids
Nausea and vomiting were measured using a scoring system(0 = no nausea, 1 = only nausea, 2 = both nausea and vomiting).
Measured: 72 hours after surgery
Time to first postoperative ambulation
Time from the end of surgery to the first postoperative ambulation
Measured: Up to 14 days after surgery
Hospital duration from operation to discharge
Time from the end of surgery to discharge from the hospital
Measured: Up to 60 days after surgery
Rate of pulmonary infection
Rate of pulmonary infection up to 30 days after surgery
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start10 Oct 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504265
- Sponsor's protocol ID
- 22/166-3367
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2022
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of Different Analgesic Modes in Minimally Invasive Esophagectomy for Esophageal Cancer
- ClinicalTrials.gov ID
- NCT05504265
- Acronym / sponsor ID
- 22/166-3367
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 17 Aug 2022 (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.
This study was designed to compare analgesic efficacy and safety of different perioperative analgesic modes in minimally invasive esophagectomy for esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Postoperative NSAIDs | Other | Drug: Postoperative flurbiprofen axetil |
| Preemptive analgesia followed by Postoperative NSAIDs | Experimental | Drug: Preemptive flurbiprofen axetil, Drug: Postoperative flurbiprofen axetil |
| Postoperative patient-controlled analgesia pump | Experimental | Device: Patient-controlled analgesia pump |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-75 years;
- Patients underwent laparoscopic and thoracoscopic or robotic-assisted minimally invasive esophagectomy ;
- Informed consent.
Key exclusion criteria (10 listed)
- Has a history of cholecystitis or urolithiasis within 3 months;
- Has a history of atherothrombosis (peripheral arterial disease), stroke, myocardial infarction;
- With lung diseases, such as pneumonia, atelectasis, emphysema, pulmonary bullae, etc;
- Preoperative cardiac function grade ≥ III or coronary artery stenosis;
- Preoperative indwelling of a thoracic drainage tube;
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 |
|---|---|---|
| Preemptive flurbiprofen axetil50mg once，30min before induction anesthesia | Drug | Preemptive analgesia followed by Postoperative NSAIDs |
| Postoperative flurbiprofen axetil50mg bid | Drug | Postoperative NSAIDs, Preemptive analgesia followed by Postoperative NSAIDs |
| Patient-controlled analgesia pumpSufentanil 2.5 μg/kg+ondansetron 8mg, prepared to 100ml normal saline; background dose: 2 ml/h, single press analgesic pump injection volume: 0.5 ml, locking time: 15 min. | Device | Postoperative patient-controlled analgesia pump |
Primary outcome
Postoperative pain score
Time frame: 4 hours after surgery
In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.
Postoperative pain score
Time frame: 12 hours after surgery
In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.
Postoperative pain score
Time frame: 24 hours after surgery
In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.
Postoperative pain score
Time frame: 36 hours after surgery
In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.
Postoperative pain score
Time frame: 48 hours after surgery
In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.
Postoperative pain score
Time frame: 60 hours after surgery
In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.
Postoperative pain score
Time frame: 72 hours after surgery
In the Visual Analog Score to be used as the pain measurement criterion, '0' is the minimum value that indicates no pain, while '10' is the maximum value that defines the most severe pain.
11 secondary outcomes
Time to first postoperative flatus
Time frame: Up to 14 days after surgery
Time to first postoperative defaecation
Time frame: Up to 14 days after surgery
Abdominal distension score
Time frame: 24 hours after surgery
Abdominal distension score
Time frame: 48 hours after surgery
Abdominal distension score
Time frame: 72 hours after surgery
Side effects related to opioids
Time frame: 24 hours after surgery
Side effects related to opioids
Time frame: 48 hours after surgery
Side effects related to opioids
Time frame: 72 hours after surgery
Time to first postoperative ambulation
Time frame: Up to 14 days after surgery
Hospital duration from operation to discharge
Time frame: Up to 60 days after surgery
Rate of pulmonary infection
Time frame: Up to 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Preemptive flurbiprofen axetil and Postoperative flurbiprofen axetil in people with Esophageal Cancer and Perioperative Analgesia, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
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 10 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 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 zhu zhixiang (13311131231, zhuzhixiang2010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain score (time frame: 4 hours after surgery). The study lists 7 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 20 Mar 2025.