Pain, Postoperative
Conditions
Keywords
postoperative pain
Brief summary
Oxycodone is one of the most widely used opioids for pain treatment. Many studies demonstrated good efficacy of oxycodone on postoperative pain. In this study, we assess the efficacy and side effects of bolus intravenous of oxycodone injection compared to those of fentanyl in patients after total hip replacement surgery.
Detailed description
Oxycodone is one of the most widely used opioids for pain treatment. There have been several studies on the efficacy and side effects of oxycodone. Oxycodone has been known to have the same potency with morphine. Many studies demonstrated good efficacy of oxycodone on postoperative pain. In this study, we designed a prospective, randomized, and double-blind study to assess the efficacy and side effects of bolus intravenous of oxycodone injection compared to those of fentanyl in patients who underwent the total hip replacement surgery.
Interventions
DRUGOxycodone
4mg of oxycodone iv 20 min before the end of surgery, 10ug/kg of fentanyl in Patient-Controlled Analgesia(PCA)
DRUGFentanyl
50ug of fentanyl iv 20 min before the end of surgery, 10ug/kg of fentanyl in Patient-Controlled Analgesia(PCA),
Sponsors
Kyunghee University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 19-65 years of age * ASA physical status classification I or II * Scheduled for total hip replacement surgery
Exclusion criteria
* Allergic to study drugs * Patient with asthma or COPD, patient who is severely respiratory depressed * Renal of hepatic insufficiency * Epileptic status * Intracranial lesion associated with increased intracranial pressure * Acute abdomen, patient who has diagnosed paralytic ileus or suspicious ileus * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain measurement using Numeric Rating Scale(NRS) | Immediately after surgery | Measure postoperative pain using NRS at the PostAnesthesia Care Unit(PACU) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional doses of fentanyl for pain management | From immediately after surgery to 2 days after surgery | 0-6 hours, 6-12 hours, 12-24 hours, 24-48 hours after surgery |
Other
| Measure | Time frame |
|---|---|
| Adverse effect | From immediately after surgery to 2 days after surgery |
Countries
South Korea
Contacts
Primary ContactYoungsoon Kim, MD, PhD
Backup ContactHee Yong Kang, MD
Outcome results
None listed