Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy

NCT02204878 | Unknown Phase 4 DMC

• 1 other identifier: PUMCH-Liver-Dynastat
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatic Hemangioma Located in the Right Liver; Laparotomy Surgery

Outcome Measures

Primary Outcomes (1)

• VAS scores change

  at rest and after activity befor and 6hrs, 18hrs, 30hrs, 42hrs, 54hrs and 66hrs after surgery

Secondary Outcomes (3)

• liver function change

  befor and 42hrs and 66hrs after surgery

• kidney function change

  befor and 42hrs and 66hrs after surgery

• blood ammonia level change

  before and 42hrs, 66hrs after surgery

Other Outcomes (6)

• ESR change

  before and 42hrs and 66hrs after surgery

• portal blood flow change

  before and after surgery

• CRP change

  before and 42hrs and 66hrs after surgery

Study Arms (2)

A

PLACEBO COMPARATOR

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

AT

EXPERIMENTAL

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

Interventions

Parecoxib Sodium DRUG

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

AT

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking union medical college hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

MeSH Terms

Interventions

parecoxib

Central Study Contacts

Shunda Du, Doctor

CONTACT

86-010-69156042; shundadu@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 30, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2015
• Last Updated: July 30, 2014

Record last verified: 2014-07

Locations

CN (1)