An observational study in Pain, Postoperative and Postoperative Nausea and Vomiting, sponsored by Severance Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-05-02.
Sponsored by Severance Hospital · Observational
In this retrospective study, postoperative pain score, PCA-related complications, the risk factors for requirement of rescue analgesics and antiemetics will be evaluated in young and elderly patients, respectively, using fentanyl-based IV PCA during postoperative 48 hours after various surgeries.
Since 2010, A PCA service team in the investigators' hospital have collected multidisciplinary clinical data from all the patients who used IV-PCA postoperatively in aim of the assessment of clinical outcome. The investigators reviewed the collected data from the patients who had used IV-PCA for pain control after an elective surgery under general or spinal anesthesia between Sep. 2010 and March. 2014. The need for informed consent was waived for this study. The investigators have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist's option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs. Exclusion criteria were as following: age \< 20 years old, age 40 to 69, postoperative ventilator support or intensive care, and imperfect data. The data of the PCA regimen which has been decided were recorded and analyzed. Demographic variables including age, sex, body mass index, American Society of Anesthesiologists (ASA) physical status and history of smoking, motion sickness, postoperative nausea/vomiting, hypertension and diabetes mellitus have been analyzed. Anesthesia and surgery-related variables including the duration of anesthesia, the type of anesthesia (general or spinal), laparoscopy and the operation site (categorized in abdominal, thoracic, upper \& lower extremities, head \& neck, spine and others) were also been analyzed. PCA-related variables included total dose of fentanyl for two days (µg/kg), use of mixed additional analgesics and antiemetics in PCA and discontinuation of PCA. When the patient requested the discontinuation of IV-PCA, the reason and the time have been recorded. Postoperative variables including the numeric rating scale (NRS, 0-10, 0 = no symptom; 10= unthinkable worst pain) for pain, requirements of rescue analgesics and antiemetics were analyzed. And the postoperative complications including nausea, vomiting, headache, dizziness, and sedation were analyzed. All the postoperative variables were recorded at postoperative 0-6 hrs including stay at post-anesthesia care unit, 6-12, 12-18, 18-24 and 24-48 hrs.
822 studies on the registry are indexed under Nausea; 104 are open to participants now.
This study's enrollment of 10,575 is above the median of 170 across 90 observational studies indexed under Nausea.
Browse Nausea studies →Severance Hospital is the lead sponsor of 50 studies on the registry; 2 are open to participants now.
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Collected data from the patients who had used IV-PCA for pain control after an elective surgery under general or spinal anesthesia between Sep. 2010 and March. 2014.
Exclusion Criteria:
Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.
Device: Fentanyl based IV-PCA
Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.
Device: Fentanyl based IV-PCA
We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist's option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs.
Also known as: Intravenous patient controlled analgesic device
Incidence of Rescue Analgesics Requirement
The percentage of patients who required rescue analgesics at least once during the postoperative 48-hour period
Time frame: Postoperative 48 hours
Incidence of Rescue Antiemetics Requirement
The proportion of patients who required rescue antiemetics at least once during the postoperative 48-hour period
Time frame: Postoperative 48 hours
Postoperative Pain in Numeric Pain Scale
The Numeric Pain Scale (NRS - 0: no pain, 10: worst pain can't imagine) for pain measured once at each time periods (0\~6, 6\~12, 12\~18, 18\~24, 24\~48 hours)
Time frame: Postoperative 48 hours
Incidence of Nausea and Vomiting
The percentage of participants who had nausea and vomiting during postoperative 48 hours
Time frame: Postoperative 48 hours
Incidence of Dizziness or Headaches
The percentage of participants who had headache and dizziness
Time frame: Postoperative 48 hours
| Milestone | Elderly Patients | Young Adults |
|---|---|---|
| Started | 4525 | 6050 |
| Completed | 4525 | 6050 |
| Not completed | 0 | 0 |
The percentage of patients who required rescue analgesics at least once during the postoperative 48-hour period
| Percentage of Participants | Elderly Patients | Young Adults |
|---|---|---|
| Incidence of Rescue Analgesics Requirement | 47.9 | 53.8 |
The proportion of patients who required rescue antiemetics at least once during the postoperative 48-hour period
| Percentage of Participants | Elderly Patients | Young Adults |
|---|---|---|
| Incidence of Rescue Antiemetics Requirement | 12.2 | 10.1 |
The Numeric Pain Scale (NRS - 0: no pain, 10: worst pain can't imagine) for pain measured once at each time periods (0\~6, 6\~12, 12\~18, 18\~24, 24\~48 hours)
| Scores on a scale | Elderly Patients | Young Adults |
|---|---|---|
| Postoperative 0-6 hours | 5.74 ± 1.90 | 5.70 ± 1.94 |
| Postoperative 6-12 hours | 4.58 ± 1.8 | 4.68 ± 1.79 |
| Postoperative 12-18 hours | 3.97 ± 1.63 | 3.91 ± 1.59 |
| Postoperative 18-24 hours | 3.32 ± 1.46 | 3.33 ± 1.45 |
| Postoperative 24-48 hours | 2.84 ± 1.32 | 2.83 ± 1.31 |
The percentage of participants who had nausea and vomiting during postoperative 48 hours
| percentage of participants | Elderly Patients | Young Adults |
|---|---|---|
| Incidence of Nausea and Vomiting | 20.6 | 23.8 |
The percentage of participants who had headache and dizziness
| percentage of participants | Elderly Patients | Young Adults |
|---|---|---|
| headache | 1.7 | 2.3 |
| dizziness | 6.5 | 9.8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Elderly Patients | — | 0/4,525 (0%) | 0/4,525 (0%) |
| Young Adults | — | 0/6,050 (0%) | 0/6,050 (0%) |
| Age, Categorical(Participants) | Elderly Patients | Young Adults | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 6050 | 6050 |
| >=65 years | 4525 | 0 | 4525 |
| Age, Continuous(years) | Elderly Patients | Young Adults | Total |
|---|---|---|---|
| Mean | 74.8 ± 4.4 | 31.7 ± 5.8 | 57.8 ± 5.2 |
| Sex: Female, Male(Participants) | Elderly Patients | Young Adults | Total |
|---|---|---|---|
| Female | 2169 | 3706 | 5875 |
| Male | 2356 | 2344 | 4700 |
| Region of Enrollment(participants) | Elderly Patients | Young Adults | Total |
|---|---|---|---|
| Korea, Republic of | 4525 | 6050 | 10575 |
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Severance Hospital