Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery

Study Overview
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Brief Summary
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Postoperative pain control is required after major abdominal surgery, including laparoscopic colorectal surgery. Intravenous oxycodone is widely used for postoperative acute pain control mainly in Europe. The aim of this study is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic colorectal surgery in Korean.

Detailed Description
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Oxycodone is known to be effective in pain control and has less sedative effect than morphine does. It has been described that distribution of cytochrome P450, which is associated with metabolism of oxycodone, differed between the races. Proper dose of intravenous oxycodone after major abdominal surgery has not been well defined in Korean. The purpose of this study is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic colorectal surgery in Korean based on pain score and side effects.

Official Title
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Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery

Conditions
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Pain

Intervention / Treatment
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* Drug: Oxycodone, 1.00 mg dose
* Drug: Oxycodone, 0.03 mg/kg dose
* Drug: Oxycodone, 0.02 mg/kg dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists class 1,2 Expected surgical time between 2 - 6 hours Scheduled for laparoscopic colorectal surgery Exclusion Criteria: Severe dysfunction of liver, heart, kidney, or lung Cannot understand numeric rating scale of pain Known or suspected allergy to oxycodone Previous history of postoperative nausea or vomiting Medication of antidepressants Postoperative long-term ICU care or prolonged mechanical ventilatory support Chronic pain Drug abuser Hypersensitivity reaction to aspirin or NSAIDs Refuse to enroll

Ages Eligible for Study
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Minimum Age: 20 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxycodone, 1.00 mg dose<br>Regimen of intravenous patient-controlled analgesia consists of bolus dose of oxycodone 1.00 mg with lock out time of 10 min without basal infusion. | Drug: Oxycodone, 1.00 mg dose<br>* Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 1.00 mg.<br>* Other names: OxyNorm;|
| Experimental: Oxycodone, 0.03 mg/kg dose<br>Regimen of intravenous patient-controlled analgesia consists of bolus dose of oxycodone 0.03 mg/kg with lock out time of 10 min without basal infusion. | Drug: Oxycodone, 0.03 mg/kg dose<br>* Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.03 mg/kg.<br>* Other names: OxyNorm;|
| Experimental: Oxycodone, 0.02 mg/kg dose<br>Regimen of intravenous patient-controlled analgesia consists of bolus dose of oxycodone 0.02 mg/kg with lock out time of 10 min without basal infusion. | Drug: Oxycodone, 0.02 mg/kg dose<br>* intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.02 mg/kg.<br>* Other names: OxyNorm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resting postoperative pain at 24hr | Primary outcome is resting postoperative pain at 24 hr after surgery with numeric rating scale 0-10. | 24 hr after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects | Secondary outcome includes any side effect at 24 hr after surgery. | 24 hr after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute pain, postoperative, surgery