Pain, Postoperative
Conditions
Keywords
pharmacogenetics
Brief summary
Fentanyl is a widely used opioid analgesic. There are big interindividual variabilities in dose requirements of fentanyl for postoperative pain control. This study aims to reveal the genetic factors affecting the variable requirements of fentanyl during postoperative period.
Detailed description
The candidate genes are OPRM1, ABCB1,CYP3A4 and CYP3A5.
Interventions
None listed
Sponsors
Inje University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing total abdominal hysterectomy (TAH) or laparoscopy assisted vaginal hysterectomy (LAVH) under general anesthesia * Patients who want to use intravenous patient controlled analgesia (PCA) after surgery * ASA physical status class I, II
Exclusion criteria
* history of drug addiction * opioid medication within 12 hours before surgery * previous history of opioid medication for 3 months * neurologic disorder * cardiac disorder * hepatic disease * renal disease * respiratory disease such as COPD, asthma * sleep apnea * BMI \> 30 * psycotic disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative Cumulative Fentanyl Consumption | 24 hr after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative Cumulative Fentanyl Consumption | 48hr after surgery |
Countries
South Korea
Participant flow
Recruitment details
* Dates of recruitment: 2008 Sep - 2010 Feb * Type of location: university hospital
Pre-assignment details
No group assignment required for this study.
Participants by arm
| Arm | Count |
|---|---|
| Gynecologic Patients Undergoing TAH, LAVH * Inclusion criteria:
19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia
* Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity | 204 |
| Total | 204 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Gynecologic Patients Undergoing TAH, LAVH |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 204 Participants |
| Age Continuous | 45.3 years STANDARD_DEVIATION 4.9 |
| Region of Enrollment Korea, Republic of | 204 participants |
| Sex: Female, Male Female | 204 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 204 |
| serious Total, serious adverse events | 0 / 204 |
Outcome results
Primary
Postoperative Cumulative Fentanyl Consumption
Time frame: 24 hr after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gynecologic Patients Undergoing TAH, LAVH | Postoperative Cumulative Fentanyl Consumption | 836 mcg | Standard Deviation 416 |
Secondary
Postoperative Cumulative Fentanyl Consumption
Time frame: 48hr after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gynecologic Patients Undergoing TAH, LAVH | Postoperative Cumulative Fentanyl Consumption | 1028 mcg | Standard Deviation 520 |