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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
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Tracking Information
First Submitted Date  ICMJE July 28, 2014
First Posted Date  ICMJE July 30, 2014
Last Update Posted Date July 30, 2014
Study Start Date  ICMJE July 2014
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
VAS scores change [ Time Frame: at rest and after activity befor and 6hrs, 18hrs, 30hrs, 42hrs, 54hrs and 66hrs after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 29, 2014)
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy
Official Title  ICMJE A Randomized, Phase IV Study Exploring the Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy
Brief Summary To searching the role of parecoxib sodium for postoperative pain management in open hepatectomy
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatic Hemangioma Located in the Right Liver
  • Laparotomy Surgery
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Parecoxib Sodium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 29, 2014)
100
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02204878
Other Study ID Numbers  ICMJE PUMCH-Liver-Dynastat
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peking Union Medical College Hospital
Study Sponsor  ICMJE Peking Union Medical College Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Peking Union Medical College Hospital
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP