NCT02732262

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P25-P50 for phase_3 pain

Timeline
Completed

Started Apr 2016

Typical duration for phase_3 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

May 16, 2019

Status Verified

May 1, 2019

Enrollment Period

2.2 years

First QC Date

April 4, 2016

Last Update Submit

May 14, 2019

Conditions

Pain

Keywords

acute painpostoperativesurgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Side effects

    24 hr after surgery

Other Outcomes (1)

  • Sedation

    24 hr after surgery

Study Arms (3)

Oxycodone, 1.00 mg dose

EXPERIMENTAL

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

Oxycodone, 0.03 mg/kg dose

EXPERIMENTAL

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

Oxycodone, 0.02 mg/kg dose

EXPERIMENTAL

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

Interventions

Oxycodone, 1.00 mg doseDRUG

Intravenous oxycodone is provided as patientcontrolled analgesia after surgery with bolus dose of 1.00 mg.

Also known as: OxyNorm
Oxycodone, 1.00 mg dose
Oxycodone, 0.03 mg/kg doseDRUG

Intravenous oxycodone is provided as patientcontrolled analgesia after surgery with bolus dose of 0.03 mg/kg.

Also known as: OxyNorm
Oxycodone, 0.03 mg/kg dose
Oxycodone, 0.02 mg/kg doseDRUG

Intravenous oxycodone is provided as patientcontrolled analgesia after surgery with bolus dose of 0.02 mg/kg.

Also known as: OxyNorm
Oxycodone, 0.02 mg/kg dose

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists class 1, 2
  • Expected surgical time between 2\~ 6hours
  • Scheduled for laparoscopic colorectal surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

PainAcute Pain

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

April 4, 2016

First Posted

April 8, 2016

Study Start

April 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

May 16, 2019

Record last verified: 2019-05

Locations

KR(1)