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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-12-31

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.

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Oxycodone, 1.00 mg dose

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.

Group Type EXPERIMENTAL

Oxycodone, 1.00 mg dose

Intervention Type DRUG

Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 1.00 mg.

Oxycodone, 0.03 mg/kg dose

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.

Group Type EXPERIMENTAL

Oxycodone, 0.03 mg/kg dose

Intervention Type DRUG

Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.03 mg/kg.

Oxycodone, 0.02 mg/kg dose

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.

Group Type EXPERIMENTAL

Oxycodone, 0.02 mg/kg dose

Intervention Type DRUG

intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.02 mg/kg.

Interventions

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Oxycodone, 1.00 mg dose

Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 1.00 mg.

Intervention Type DRUG

Oxycodone, 0.03 mg/kg dose

Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.03 mg/kg.

Intervention Type DRUG

Oxycodone, 0.02 mg/kg dose

intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.02 mg/kg.

Intervention Type DRUG

Other Intervention Names

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OxyNorm OxyNorm OxyNorm

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No