Optimal Dose of i.v Oxycodone for Postoperative Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Oxycodone, 1.00 mg dose; Drug: Oxycodone, 0.03 mg/kg dose; Drug: Oxycodone, 0.02 mg/kg dose

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 Type: Interventional
• Enrollment (Actual): 134
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American Society of Anesthesiologists class 1, 2
• Expected surgical time between 2~ 6hours
• 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 longterm
• ICU care or prolonged mechanical ventilatory support
• Chronic pain
• Drug abuser
• Hypersensitivity reaction to aspirin or NSAIDs
• Refuse to enroll

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxycodone, 1.00 mg dose; Regimen of intravenous patientcontrolled 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; Intravenous oxycodone is provided as patientcontrolled analgesia after surgery with bolus dose of 1.00 mg.; Other Names: OxyNorm
Experimental: Oxycodone, 0.03 mg/kg dose; Regimen of intravenous patientcontrolled 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; Intravenous oxycodone is provided as patientcontrolled analgesia after surgery with bolus dose of 0.03 mg/kg.; Other Names: OxyNorm
Experimental: Oxycodone, 0.02 mg/kg dose; Regimen of intravenous patientcontrolled 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; Intravenous oxycodone is provided as patientcontrolled analgesia after surgery with bolus dose of 0.02 mg/kg.; Other Names: OxyNorm

What is the study measuring?

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 010.	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation	sedation with Ramsay sedation score (1-6) at 24 hr after surgery	24 hr after surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: April 4, 2016
• First Submitted That Met QC Criteria: April 4, 2016
• First Posted (Estimate): April 8, 2016

Study Record Updates

• Last Update Posted (Actual): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: surgery; acute pain; postoperative
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• Other Study ID Numbers: JHSeo-Oxynorm