Hepatic Hemangioma Located in the Right LiverPhase 4NCT02204878
Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy
A Phase 4 study testing Parecoxib Sodium in people with Hepatic Hemangioma Located in the Right Liver and Laparotomy Surgery, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
To searching the role of parecoxib sodium for postoperative pain management in open hepatectomy Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hepatic Hemangioma Located in the Right Liver, Laparotomy Surgery
- What is being tested?
- Parecoxib Sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Aug 2015
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20-70 years old;
- Hepatic hemangioma patients who will undergo laparotomy surgery: diameter of hepatic hemangioma between 5-15cm, located in the right liver;
- Child score 5-6;
- BMI: 19-25;
- ASA: Ⅰ ~ Ⅱ grade;
- No comorbidities such as diabetes, hypertension, cardio renal or respiratory dysfunction, mental illness;
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- No known allergies;
- No participation in other clinical trials within 2 months;
- Have been informed consent.
- Surgery-related: right subcostal incision, surgical time< 4 hours, hepatic pedicle occlusion time< 20 minutes, bleeding< 1000ml, no blood transfusions.
Who cannot join
- History of chronic pain，long-term use of analgesic drugs or alcohol abuse;
- Allergic to NSAIDs, opioids or sulfa drugs;
- Coagulopathy or other hematological disorder；
- Active peptic ulcer, gastrointestinal bleeding, inflammatory bowel disease;
- Pregnant or lactating;
- Mentally unstable to use PCA;
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- Preoperative pain caused by other disease;
- Analgesic drugs or NSAIDs intake one week before surgery;
- Preoperative systemic inflammatory response syndrome;
- Preoperative chemotherapy or radiotherapy;
- Preoperative or postoperative use of steroids;
- Operative time> 4 hours, hepatic pedicle occlusion time> 20 minutes, blood loss> 1000ml, or intraoperative blood transfusion;
- TBil> 34 umol/L、PT prolongation> 3S、ALB< 30 g/L、or Child score> 7 within 42 hours after surgery；
- Bleeding、biliary fistula, intra-abdominal infections or other postoperative complications.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking union medical college hospital
Beijing, Beijing Municipality, 100032
Shunda Du, Doctor, 8613911832900, shundadu@sina.com
Shunda Du, Doctor
About this study
Official title: A Randomized, Phase IV Study Exploring the Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy
To searching the role of parecoxib sodium for postoperative pain management in open hepatectomy
- Being tested
- Parecoxib Sodium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parecoxib SodiumDrug
Dynastat 40mg was given before anesthesia. PCA will be attached right before closing abdomen. Concentration of sufentanil is 1ug/ml. PCA settings: 1) no background infusion; 2) bolus 2ml sufentanil each; 3) with the lockout time 5 min, 1 hour limit: 10ml. Dynastat 40mg Q12h will be given within 72 hours after surgery
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | 1ml of saline was given before anesthesia. PCA will be attached right before closing abdomen. Concentration of sufentanil is 1ug/ml. PCA settings: 1) no background infusion; 2) bolus 2ml sufentanil each; 3) with the lockout time 5 min, 1 hour limit: 10ml. 1ml saline Q12h will be given within 72 hours after surgery |
| AT | Experimental | Dynastat 40mg was given before anesthesia. PCA will be attached right before closing abdomen. Concentration of sufentanil is 1ug/ml. PCA settings: 1) no background infusion; 2) bolus 2ml sufentanil each; 3) with the lockout time 5 min, 1 hour limit: 10ml. Dynastat 40mg Q12h will be given within 72 hours after surgery Receives: Drug: Parecoxib Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS scores change
Measured: at rest and after activity befor and 6hrs, 18hrs, 30hrs, 42hrs, 54hrs and 66hrs after surgery
Secondary outcomes (3)
liver function change
Measured: befor and 42hrs and 66hrs after surgery
kidney function change
Measured: befor and 42hrs and 66hrs after surgery
blood ammonia level change
Measured: before and 42hrs, 66hrs after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Hemangioma Located in the Right LiverStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204878
- Sponsor's protocol ID
- PUMCH-Liver-Dynastat
- Status last verified
- Jul 2014
- First submitted
- 28 Jul 2014
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase IV Study Exploring the Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy
- ClinicalTrials.gov ID
- NCT02204878
- Acronym / sponsor ID
- PUMCH-Liver-Dynastat
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Aug 2015 (estimated)
- First posted
- 30 Jul 2014 (estimated)
- 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.
To searching the role of parecoxib sodium for postoperative pain management in open hepatectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | –1ml of saline was given before anesthesia. PCA will be attached right before closing abdomen. Concentration of sufentanil is 1ug/ml. PCA settings: 1) no background infusion; 2) bolus 2ml sufentanil each; 3) with the lockout time 5 min, 1 hour limit: 10ml. 1ml saline Q12h will be given within 72 hours after surgery |
| AT | Experimental | Drug: Parecoxib SodiumDynastat 40mg was given before anesthesia. PCA will be attached right before closing abdomen. Concentration of sufentanil is 1ug/ml. PCA settings: 1) no background infusion; 2) bolus 2ml sufentanil each; 3) with the lockout time 5 min, 1 hour limit: 10ml. Dynastat 40mg Q12h will be given within 72 hours after surgery |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age between 20-70 years old;
- Hepatic hemangioma patients who will undergo laparotomy surgery: diameter of hepatic hemangioma between 5-15cm, located in the right liver;
- Child score 5-6;
- BMI: 19-25;
- ASA: Ⅰ ~ Ⅱ grade;
Key exclusion criteria (14 listed)
- History of chronic pain，long-term use of analgesic drugs or alcohol abuse;
- Allergic to NSAIDs, opioids or sulfa drugs;
- Coagulopathy or other hematological disorder；
- Active peptic ulcer, gastrointestinal bleeding, inflammatory bowel disease;
- Pregnant or lactating;
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 |
|---|---|---|
| Parecoxib SodiumDynastat 40mg was given before anesthesia. PCA will be attached right before closing abdomen. Concentration of sufentanil is 1ug/ml. PCA settings: 1) no background infusion; 2) bolus 2ml sufentanil each; 3) with the lockout time 5 min, 1 hour limit: 10ml. Dynastat 40mg Q12h will be given within 72 hours after surgery | Drug | AT |
Primary outcome
VAS scores change
Time frame: at rest and after activity befor and 6hrs, 18hrs, 30hrs, 42hrs, 54hrs and 66hrs after surgery
3 secondary outcomes
liver function change
Time frame: befor and 42hrs and 66hrs after surgery
kidney function change
Time frame: befor and 42hrs and 66hrs after surgery
blood ammonia level change
Time frame: before and 42hrs, 66hrs after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2014.
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 4 study testing Parecoxib Sodium in people with Hepatic Hemangioma Located in the Right Liver and Laparotomy Surgery, run by Peking Union Medical College Hospital 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 10 inclusion and 14 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 30 Jul 2014. 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. Some participants in this study may receive a placebo. 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 Shunda Du, Doctor (86-010-69156042, shundadu@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS scores change (time frame: at rest and after activity befor and 6hrs, 18hrs, 30hrs, 42hrs, 54hrs and 66hrs after surgery). 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 30 Jul 2014.