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

Study Overview
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Brief Summary
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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.

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Procedure: conventional intravenous infusion pump
* Drug: parecoxib
* Procedure: intravenous infusion pump of patient-controlled analgesia
* Drug: fentanyl citrate+ ondansetron hydrochloride + normal saline
* Drug: celecoxib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: conventional intravenous infusion pump<br>The first group receives conventional intravenous infusion pump of patient-controlled analgesia. | Procedure: conventional intravenous infusion pump<br>* 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.<br>Drug: fentanyl citrate+ ondansetron hydrochloride + normal saline<br> <br> |
| Experimental: parecoxib<br>The second group has oral celecoxib before surgery, then receives parecoxib sodium intravenously guttae after surgery. | Drug: parecoxib<br>* The second group has oral celecoxib before surgery, then receives 40 mg parecoxib sodium intravenously guttae twice a day for three days after surgery.<br>* Other names: CAS number: 202409-33-4;Drug: celecoxib<br> <br> |
| Experimental: new intravenous infusion pump<br>The third group uses new intravenous infusion pump of patient-controlled analgesia after surgery. | Drug: parecoxib<br>* The second group has oral celecoxib before surgery, then receives 40 mg parecoxib sodium intravenously guttae twice a day for three days after surgery.<br>* Other names: CAS number: 202409-33-4;Procedure: intravenous infusion pump of patient-controlled analgesia<br>* 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.<br>Drug: celecoxib<br> <br> |

What is the study measuring?
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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 |