Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy

Laparotomy Surgery Clinical Trial

Official title:

A Randomized, Phase IV Study Exploring the Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02204878
• Other study ID #: PUMCH-Liver-Dynastat
• Status: Recruiting
• Phase: Phase 4
• First received: July 28, 2014
• Last updated: July 29, 2014
• Start date: July 2014

Study information

• Verified date: July 2014
• Source: Peking Union Medical College Hospital
• Contact: Shunda Du, Doctor
• Phone: 86-010-69156042
• Email: shundadu[@]sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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: ? ~ ? 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemangioma
• Hepatic Hemangioma Located in the Right Liver
• Laparotomy Surgery
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
China	Peking union medical college hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ESR change		before and 42hrs and 66hrs after surgery	No
Other	portal blood flow change	Ultrasound evaluation	before and after surgery	No
Other	CRP change		before and 42hrs and 66hrs after surgery	No
Other	IL4 change		before and 42hrs and 66hrs after surgery	No
Other	IL6 change		before and 42hrs and 66hrs after surgery	No
Other	portal blood pressure change	Ultrasound evaluation	before and after surgery	No
Primary	VAS scores change		at rest and after activity befor and 6hrs, 18hrs, 30hrs, 42hrs, 54hrs and 66hrs after surgery	No
Secondary	liver function change		befor and 42hrs and 66hrs after surgery	No
Secondary	kidney function change		befor and 42hrs and 66hrs after surgery	No
Secondary	blood ammonia level change		before and 42hrs, 66hrs after surgery	No