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

Phase 3

Withdrawn

• Conditions: Pain
• Interventions: Drug: Oxycodone, 0.03 mg/kg dose; Drug: Oxycodone, 1.00 mg dose; Drug: Oxycodone, 0.02 mg/kg dose

• Registration Number: NCT02240602
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2014-09
• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-15
• Last Update Submitted: 2015-06-14
• Last Update Posted: 2015-06-16
• Study Start: 2015-07
• Primary Completion: 2016-10
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• American Society of Anesthesiologists class 1,2
• Expected surgical time between 2 - 6 hours
• Scheduled for laparoscopic colorectal surgery

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxycodone, 0.03 mg/kg dose	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.
Oxycodone, 1.00 mg dose	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.
Oxycodone, 0.02 mg/kg dose	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.

Primary Outcome Measures

Name	Time	Method
resting postoperative pain at 24hr	24 hr after surgery	Primary outcome is resting postoperative pain at 24 hr after surgery with numeric rating scale 0-10.

Secondary Outcome Measures

Name	Time	Method
side effects	24 hr after surgery	Secondary outcome includes any side effect at 24 hr after surgery.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of