Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy
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ClinicalTrials.gov Identifier: NCT02204878 |
Recruitment Status : Unknown
Verified July 2014 by Peking Union Medical College Hospital.
Recruitment status was: Recruiting
First Posted : July 30, 2014
Last Update Posted : July 30, 2014
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Condition or disease | Intervention/treatment | Phase |
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Hepatic Hemangioma Located in the Right Liver Laparotomy Surgery | Drug: Parecoxib Sodium | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Phase IV Study Exploring the Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy |
Study Start Date : | July 2014 |
Estimated Primary Completion Date : | August 2015 |

Arm | Intervention/treatment |
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Placebo Comparator: A
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
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Experimental: AT
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
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Drug: Parecoxib Sodium
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 |
- VAS scores change [ Time Frame: at rest and after activity befor and 6hrs, 18hrs, 30hrs, 42hrs, 54hrs and 66hrs after surgery ]
- 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 ]
- ESR change [ Time Frame: before and 42hrs and 66hrs after surgery ]
- portal blood flow change [ Time Frame: before and after surgery ]Ultrasound evaluation
- CRP change [ Time Frame: before and 42hrs and 66hrs after surgery ]
- IL4 change [ Time Frame: before and 42hrs and 66hrs after surgery ]
- IL6 change [ Time Frame: before and 42hrs and 66hrs after surgery ]
- portal blood pressure change [ Time Frame: before and after surgery ]Ultrasound evaluation

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Ages Eligible for Study: | 20 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- 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;
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204878
Contact: Shunda Du, Doctor | 86-010-69156042 | shundadu@sina.com |
China, Beijing | |
Peking union medical college hospital | Recruiting |
Beijing, Beijing, China, 100032 | |
Contact: Shunda Du, Doctor 8613911832900 shundadu@sina.com | |
Principal Investigator: Shunda Du, Doctor |
Responsible Party: | Peking Union Medical College Hospital |
ClinicalTrials.gov Identifier: | NCT02204878 |
Other Study ID Numbers: |
PUMCH-Liver-Dynastat |
First Posted: | July 30, 2014 Key Record Dates |
Last Update Posted: | July 30, 2014 |
Last Verified: | July 2014 |
Hemangioma Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms Parecoxib Cyclooxygenase 2 Inhibitors |
Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents |