Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02240602
Recruitment Status : Withdrawn (Lack of internal resources)
First Posted : September 15, 2014
Last Update Posted : June 16, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain Drug: Oxycodone, 1.00 mg dose Drug: Oxycodone, 0.03 mg/kg dose Drug: Oxycodone, 0.02 mg/kg dose Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery
Study Start Date : July 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: OxyNorm




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. side effects [ Time Frame: 24 hr after surgery ]
    Secondary outcome includes any side effect at 24 hr after surgery.


Other Outcome Measures:
  1. sedation [ Time Frame: 24 hr after surgery ]
    sedation with Ramsay sedation score (1-6) at 24 hr after surgery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240602


Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Yunseok Jeon, PhD Seoul National University Hospital

Layout table for additonal information
Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02240602     History of Changes
Other Study ID Numbers: OxyNorm
First Posted: September 15, 2014    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: September 2014

Keywords provided by Seoul National University Hospital:
acute pain
postoperative
surgery

Additional relevant MeSH terms:
Layout table for MeSH terms
Oxycodone
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents