Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy

Overview

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

Full Title of Study: “A Randomized, Phase IV Study Exploring the Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: August 2015

Interventions

  • 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

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • VAS scores change
    • Time Frame: at rest and after activity befor and 6hrs, 18hrs, 30hrs, 42hrs, 54hrs and 66hrs after surgery

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peking Union Medical College Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Shunda Du, Doctor, 86-010-69156042, shundadu@sina.com

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