The Effect of Parecoxib Sodium Intravenous Patient-controlled Analgesia in Laparotomic Liver Resection

Pain, Postoperative Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02408146
• Other study ID #: Lianxin-001
• Status: Recruiting
• Phase: N/A
• First received: April 1, 2014
• Last updated: April 2, 2015
• Start date: January 2014

Study information

• Verified date: March 2014
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: Lianxin Liu, M.D.
• Phone: 86-451-85553886
• Email: liulianxin[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesized that using new intravenous infusion pump of patient-controlled analgesia (parecoxib sodium 1 mg/mL + normal saline) would significantly improve postoperative pain control compare to conventional intravenous infusion pump of patient-controlled analgesia (fentanyl citrate 20 mg/mL/kg + ondansetron hydrochloride 16 mg/8 mL + normal saline). This prospective randomized controlled trial was designed to evaluate the benefit of new intravenous infusion pump of patient-controlled analgesia (parecoxib sodium 1 mg/mL + normal saline) for postoperative analgesia after laparotomic liver resection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Patients need laparotomic liver resection.

Exclusion Criteria:

Patients with contraindications to spinal anesthesia or intrathecal morphine, difficulty understanding passive cutaneous anaphylaxis, a history of drug dependence or chronic pain, body mass index greater than 35 kg/m2, or history of sleep apnea were excluded from this study.

Study Design

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• conventional intravenous infusion pump
The first group receives conventional intravenous infusion pump of patient-controlled analgesia (fentanyl citrate 20 mg/mL/kg + ondansetron hydrochloride 16 mg/8 mL + normal saline) for three days after surgery. The pump is infused continuously at the basic flow rate of 2 mL/h, 0.5 mL of bolus can be injected if the patients press the button once upon experiencing pain. The lock-out time for each bolus injection is 15 minutes.

Drug:
• parecoxib
The second group has oral celecoxib before surgery, then receives 40 mg parecoxib sodium intravenously guttae twice a day for three days after surgery.

Procedure:
• intravenous infusion pump of patient-controlled analgesia
The third group has oral celecoxib before surgery, and receives 40 mg parecoxib sodium intravenously guttae immediately after surgery, then uses new intravenous infusion pump of patient-controlled analgesia (parecoxib sodium 1 mg/mL + normal saline) for three days after surgery. The pump is infused continuously at the basic flow rate of 2 mL/h, 0.5 mL of bolus can be injected if the patients press the button once upon experiencing pain. The lock-out time for each bolus injection is 15 minutes.

Drug:
• fentanyl citrate+ ondansetron hydrochloride + normal saline

• celecoxib

Locations

Country	Name	City	State
China	harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The measure is a composite outcome measure consisting of multiple measures,pain scores, sedation, nausea, pruritus, and respiratory rate.	Pain scores are evaluated with a visual analog scale of 0 to 100 and are measured at rest and with movement such as cough or incentive spirometry at 6, 9, 12, 18, 24, 36, 48 and 72 hours. Sedation, nausea, and pruritus are also measured at 6, 9, 12, 18, 24, 36, 48 and 72 hours. All the measures count together to get a composite outcome.	With or without changes in the three days after surgery	Yes