Pain
Conditions
Keywords
acute pain, postoperative, 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.
Interventions
Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 1.00 mg.
Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.03 mg/kg.
intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.02 mg/kg.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| resting postoperative pain at 24hr | 24 hr after surgery | Primary outcome is resting postoperative pain at 24 hr after surgery with numeric rating scale 0-10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| side effects | 24 hr after surgery | Secondary outcome includes any side effect at 24 hr after surgery. |
Other
| Measure | Time frame | Description |
|---|---|---|
| sedation | 24 hr after surgery | sedation with Ramsay sedation score (1-6) at 24 hr after surgery |
Countries
South Korea
Outcome results
None listed