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

Primary Purpose

Pain

Status
Withdrawn
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Oxycodone, 1.00 mg dose
Oxycodone, 0.03 mg/kg dose
Oxycodone, 0.02 mg/kg dose
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring acute pain, postoperative, surgery

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Oxycodone, 1.00 mg dose

Oxycodone, 0.03 mg/kg dose

Oxycodone, 0.02 mg/kg dose

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 11, 2014
Last Updated
June 14, 2015
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02240602
Brief Title
Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery
Official Title
Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of internal resources
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
acute pain, postoperative, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxycodone, 1.00 mg dose
Arm Type
Experimental
Arm Description
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.
Arm Title
Oxycodone, 0.03 mg/kg dose
Arm Type
Experimental
Arm Description
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.
Arm Title
Oxycodone, 0.02 mg/kg dose
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxycodone, 1.00 mg dose
Other Intervention Name(s)
OxyNorm
Intervention Description
Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 1.00 mg.
Intervention Type
Drug
Intervention Name(s)
Oxycodone, 0.03 mg/kg dose
Other Intervention Name(s)
OxyNorm
Intervention Description
Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.03 mg/kg.
Intervention Type
Drug
Intervention Name(s)
Oxycodone, 0.02 mg/kg dose
Other Intervention Name(s)
OxyNorm
Intervention Description
intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.02 mg/kg.
Primary Outcome Measure Information:
Title
resting postoperative pain at 24hr
Description
Primary outcome is resting postoperative pain at 24 hr after surgery with numeric rating scale 0-10.
Time Frame
24 hr after surgery
Secondary Outcome Measure Information:
Title
side effects
Description
Secondary outcome includes any side effect at 24 hr after surgery.
Time Frame
24 hr after surgery
Other Pre-specified Outcome Measures:
Title
sedation
Description
sedation with Ramsay sedation score (1-6) at 24 hr after surgery
Time Frame
24 hr after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunseok Jeon, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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

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