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Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
To searching the role of parecoxib sodium for postoperative pain management in open hepatectomy

Condition or disease Intervention/treatment Phase
Hepatic Hemangioma Located in the Right Liver Laparotomy Surgery Drug: Parecoxib Sodium Phase 4

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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
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




Primary Outcome Measures :
  1. VAS scores change [ Time Frame: at rest and after activity befor and 6hrs, 18hrs, 30hrs, 42hrs, 54hrs and 66hrs after surgery ]

Secondary Outcome Measures :
  1. liver function change [ Time Frame: befor and 42hrs and 66hrs after surgery ]
  2. kidney function change [ Time Frame: befor and 42hrs and 66hrs after surgery ]
  3. blood ammonia level change [ Time Frame: before and 42hrs, 66hrs after surgery ]

Other Outcome Measures:
  1. ESR change [ Time Frame: before and 42hrs and 66hrs after surgery ]
  2. portal blood flow change [ Time Frame: before and after surgery ]
    Ultrasound evaluation

  3. CRP change [ Time Frame: before and 42hrs and 66hrs after surgery ]
  4. IL4 change [ Time Frame: before and 42hrs and 66hrs after surgery ]
  5. IL6 change [ Time Frame: before and 42hrs and 66hrs after surgery ]
  6. 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
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Shunda Du, Doctor 86-010-69156042 shundadu@sina.com

Locations
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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         
Sponsors and Collaborators
Peking Union Medical College Hospital
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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
Additional relevant MeSH terms:
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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