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

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.

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: celecoxib; Procedure: conventional intravenous infusion pump; Drug: fentanyl citrate+ ondansetron hydrochloride + normal saline; Drug: parecoxib; Procedure: intravenous infusion pump of patient-controlled analgesia

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150086
      • Recruiting
      • Harbin Medical University
      • Contact: Jiabei Wang, PhD; Phone Number: 86-451-85555049; Email: inn_2001@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: conventional intravenous infusion pump; The first group receives conventional intravenous infusion pump of patient-controlled analgesia.	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: fentanyl citrate+ ondansetron hydrochloride + normal saline
Experimental: parecoxib; The second group has oral celecoxib before surgery, then receives parecoxib sodium intravenously guttae after surgery.	Drug: celecoxib; 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.; Other Names: CAS number: 202409-33-4
Experimental: new intravenous infusion pump; The third group uses new intravenous infusion pump of patient-controlled analgesia after surgery.	Drug: celecoxib; 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.; Other Names: CAS number: 202409-33-4; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Harbin Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: April 1, 2014
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (Estimate): April 3, 2015

Study Record Updates

• Last Update Posted (Estimate): April 3, 2015
• Last Update Submitted That Met QC Criteria: April 2, 2015
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Analgesics, Opioid; Narcotics; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Adjuvants, Anesthesia; Anti-Anxiety Agents; Cyclooxygenase 2 Inhibitors; Antipruritics; Fentanyl; Celecoxib; Ondansetron; Parecoxib
• Other Study ID Numbers: Lianxin-001