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

June 14, 2015 updated by: Seoul National University Hospital
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

Withdrawn

Conditions

Intervention / Treatment

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

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 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 - 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Oxycodone, 1.00 mg dose
Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 1.00 mg.
Other Names:
  • OxyNorm
Experimental: 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.
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.
Other Names:
  • OxyNorm
Experimental: 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.
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.
Other Names:
  • OxyNorm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
resting postoperative pain at 24hr
Time Frame: 24 hr after surgery
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
Time Frame: 24 hr after surgery
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
Time Frame: 24 hr after surgery
sedation with Ramsay sedation score (1-6) at 24 hr after surgery
24 hr after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

September 11, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 15, 2014

Study Record Updates

Last Update Posted (Estimate)

June 16, 2015

Last Update Submitted That Met QC Criteria

June 14, 2015

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OxyNorm

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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