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

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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Recruitment Status : Withdrawn (Lack of internal resources)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

Tracking Information
First Submitted Date  ICMJE September 11, 2014
First Posted Date  ICMJE September 15, 2014
Last Update Posted Date June 16, 2015
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2014)
side effects [ Time Frame: 24 hr after surgery ]
Secondary outcome includes any side effect at 24 hr after surgery.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 11, 2014)
sedation [ Time Frame: 24 hr after surgery ]
sedation with Ramsay sedation score (1-6) at 24 hr after surgery
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery
Official Title  ICMJE Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Oxycodone, 1.00 mg dose
  • 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.
    Intervention: Drug: Oxycodone, 0.03 mg/kg dose
  • 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.
    Intervention: Drug: Oxycodone, 0.02 mg/kg dose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 14, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2014)
135
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02240602
Other Study ID Numbers  ICMJE OxyNorm
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yunseok Jeon, PhD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP