Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment

Study Overview
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Brief Summary
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To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA) in the pain relieving treatment during 48h postoperative period, by comparing with morphine i.v. PCA.

Official Title
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A Prospective, Randomized, Blind, Multicentre, Parallel Group Study to Investigate the Efficacy and Safety of Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment

Conditions
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Other Acute Postoperative Pain

Intervention / Treatment
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* Drug: Oxycodone
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of either sex aged 18 to 65 years old, with a standard body weight [standard body weight = height (cm) - 100] ±15%. ASA I and II. Scheduled on elective open upper abdominal surgery under general anesthesia (liver, gall bladder, spleen, stomach, kidney, colon surgery), of which predicted operation duration is between 2-4h. Hospitalized patients on non-emergency condition who have been given appropriate preoperative treatments. Patients who are willing to participate in the study and have signed the written informed consent. Negative pregnancy test result should be obtained for women of child-bearing age. Exclusion Criteria: Long-term analgesics or psychotropic drugs (including opioids, NSAIDs, sedatives, antidepressants) taken for the chronic pain, or patients abusing alcohol. Body weight is less than or over ±15% of the standard body weight. Severe impairment of liver and renal function at preoperative stage (ALT, AST, BUN, Cr). Medical history of recovering from abnormal surgery anesthesia. Medical history of hypertension (Systolic blood pressure ≥180Hg, Diastolic blood pressure 110Hg). Esophagus reflux disease. Sedatives, anti-emetics, and anti-pruritic drugs were taken 24 hours before operation. Have known hypersensitivity to opioids. Monoamine oxidase inhibitors and antidepressant drugs were taken within 15 days. Patients with shock. Patients with COPD. Patients can not understand the VAS or unable to use PCA. Pregnant or parturient women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxycodone i.v.<br>To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA) | Drug: Oxycodone<br>* dosage:10mg/l dosage form:injection frequency:via PCA pump, background rate:0.5ml/h, 2ml/time duration:48 hours<br>* Other names: Oxycodone Injection;|
| Active Comparator: Morphine i.v.<br>To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA) | Drug: Morphine<br>* dosage: 10mg/ml dosage form: injection frequency: via PCA pump, background rate: 0.5ml/h, 2ml/times duration: 48 hours<br>* Other names: Morphine Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring VAS | Measuring resting and coughing VAS, assessing the intensity of pain | 3h post-operation | 
| Measuring VAS | Measuring resting and coughing VAS, assessing the intensity of pain | 24 hours post operation | 
| Measuring VAS | Measuring resting and coughing VAS, assessing the intensity of pain | 48 hours post operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage | Total dosage of study drugs within 48h. | Within 48h | 
| The dosage of other rescue analgesic drugs used within 48h post-operation. | The dosage of other rescue analgesic drugs used within 48h post-operation. | 48hrs | 
| The invalid times and the total times of PCA application | The invalid times and the total times of PCA application | 48hrs | 
| Satisfaction degree for analgesia | Satisfaction degree for analgesia after the treatment | 48hrs | 
| AE occurrence and abnormal lab value | AE and normal lab value will be recorded during the study | 48hrs |