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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02240602
• Other study ID #: OxyNorm
• Status: Withdrawn
• Phase: Phase 3
• First received: September 11, 2014
• Last updated: June 14, 2015
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: September 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative

Intervention

Drug:
• Oxycodone, 1.00 mg dose
Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 1.00 mg.
• Oxycodone, 0.03 mg/kg dose
Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.03 mg/kg.
• Oxycodone, 0.02 mg/kg dose
intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.02 mg/kg.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	sedation	sedation with Ramsay sedation score (1-6) at 24 hr after surgery	24 hr after surgery	Yes
Primary	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	Yes
Secondary	side effects	Secondary outcome includes any side effect at 24 hr after surgery.	24 hr after surgery	Yes