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

Not Applicable

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

• Registration Number: NCT02408146
• Lead Sponsor: First Affiliated Hospital of Harbin Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Status Verified: 2014-03
• Study First Submitted: 2014-04-01
• Study First Submitted QC: 2015-04-02
• Last Update Submitted: 2015-04-02
• Study First Posted: 2015-04-03
• Last Update Posted: 2015-04-03
• Primary Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
new intravenous infusion pump	intravenous infusion pump of patient-controlled analgesia	The third group uses new intravenous infusion pump of patient-controlled analgesia after surgery.
conventional intravenous infusion pump	conventional intravenous infusion pump	The first group receives conventional intravenous infusion pump of patient-controlled analgesia.
conventional intravenous infusion pump	fentanyl citrate+ ondansetron hydrochloride + normal saline	The first group receives conventional intravenous infusion pump of patient-controlled analgesia.
parecoxib	parecoxib	The second group has oral celecoxib before surgery, then receives parecoxib sodium intravenously guttae after surgery.
parecoxib	celecoxib	The second group has oral celecoxib before surgery, then receives parecoxib sodium intravenously guttae after surgery.
new intravenous infusion pump	parecoxib	The third group uses new intravenous infusion pump of patient-controlled analgesia after surgery.
new intravenous infusion pump	celecoxib	The third group uses new intravenous infusion pump of patient-controlled analgesia after surgery.

Primary Outcome Measures

Name	Time	Method
The measure is a composite outcome measure consisting of multiple measures,pain scores, sedation, nausea, pruritus, and respiratory rate.	With or without changes in the three days after surgery	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.

Trial Locations

Locations (1)

harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China