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

NCT02240602 | Withdrawn Phase 3 DMC

• 1 other identifier: OxyNorm
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

acute pain; postoperative; surgery

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 0-10.

  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 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

Oxycodone, 0.03 mg/kg dose

EXPERIMENTAL

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

Oxycodone, 0.02 mg/kg dose

EXPERIMENTAL

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

Interventions

Oxycodone, 1.00 mg dose DRUG

Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 1.00 mg.

Also known as: OxyNorm

Oxycodone, 1.00 mg dose

Oxycodone, 0.03 mg/kg dose DRUG

Intravenous oxycodone is provided as patient-controlled 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 dose DRUG

intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.02 mg/kg.

Also known as: OxyNorm

Oxycodone, 0.02 mg/kg dose

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists class 1,2
• Expected surgical time between 2 - 6 hours
• 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 long-term ICU care or prolonged mechanical ventilatory support
• Chronic pain
• Drug abuser
• Hypersensitivity reaction to aspirin or NSAIDs
• Refuse to enroll

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Pain; Acute Pain

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Yunseok Jeon, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

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: SPONSOR

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 15, 2014
• Study Start: July 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 16, 2015

Record last verified: 2014-09

Locations

KR (1)