Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02204878

Collaborator

(none)

100

Enrollment

Location

Arms

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2014

Anticipated Primary Completion Date :

Aug 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

VAS scores change [at rest and after activity befor and 6hrs, 18hrs, 30hrs, 42hrs, 54hrs and 66hrs after surgery]

Secondary Outcome Measures

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 Outcome Measures

ESR change [before and 42hrs and 66hrs after surgery]
portal blood flow change [before and after surgery]
Ultrasound evaluation
CRP change [before and 42hrs and 66hrs after surgery]
IL4 change [before and 42hrs and 66hrs after surgery]
IL6 change [before and 42hrs and 66hrs after surgery]
portal blood pressure change [before and after surgery]
Ultrasound evaluation

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking union medical college hospital	Beijing	Beijing	China	100032

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT02204878

Other Study ID Numbers:

PUMCH-Liver-Dynastat

First Posted:

Jul 30, 2014

Last Update Posted:

Jul 30, 2014

Last Verified:

Jul 1, 2014

Additional relevant MeSH terms:

Hemangioma

Pain, Postoperative

Parecoxib

Study Results

No Results Posted as of Jul 30, 2014