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This study is designed to evaluate the efficacy and safety of hydrocodone in patient-controlled intravenous analgesia (PCIA) during gynecological laparoscopy, thus to explore suitable PCIA scheme to optimize postoperative pain management for patients undergoing gynecological laparoscopic surgeries.
The controlled group will receive sulfentanil for PCIA, and the test group will receive hydrocodone for PCIA. NRS scores at 1, 6, 24 and 48 hours post-surgery will be recorded. The usage of rescue analgesics and adverse events will also be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sulfentanil group | Active Comparator | Participants in the active comparator group will receive sulfentanil for PCIA. |
|
| oxycodone group | Experimental | Participants in the experimental group will receive oxycodone for PCIA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patient controlled intravenous analgesia(PCIA) | Procedure | Patients will receive sulfentanil for PCIA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| NRS scores | Postoperative pain will be evaluated on a 11point number rating scale (NRS): 0 means no pain; and 10 means worst pain imaginable. | 6 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| NRS scores | Postoperative pain will be evaluated on a 11point number rating scale (NRS): 0 means no pain; and 10 means worst pain imaginable. | 1, 24, 48 hours after surgery |
| rescue analgesics usage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siyuan Liu, PhD | Contact | +86-85050301 | tdfylsy@ntu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated hospital of Nantong University | Recruiting | Nantong | Jiangsu | 226001 | China |
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| patient controlled intravenous analgesia(PCIA) | Procedure | Patients will receive oxycodone for PCIA. |
|
time to the first use of rescue analgesics
| from the end of surgery to the first usage (up to 48 hours post-surgery) |
| PCIA pressing times | total pressing times and effective pressing times | 48 hours after surgery |
| anal exhaust time | from the end of surgery to the first anal exhaust (up to 48 hours post-surgery) |
| adverse events | dizziness, drowsiness, nausea and vomiting, intestinal paralysis, skin itching, respiratory depression, intestinal obstruction, severe allergic reactions, and serious cardiovascular adverse events | within 48 hours after surgery |
| NRS scores | Postoperative pain will be evaluated on a 11point number rating scale (NRS): 0 means no pain; and 10 means worst pain imaginable. | 30 days after surgery |