Laparoscopic Hysterectomy
Conditions
Keywords
oxycodone, patient-controlled intravenous analgesia, laparoscopic hysterectomy
Brief summary
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.
Detailed description
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.
Interventions
Patients will receive sulfentanil for PCIA.
Sponsors
Affiliated Hospital of Nantong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* selective laparoscopic hysterectomy * general anesthesia * ASA classification I - III * aged 18 - 65 years
Exclusion criteria
* allergy to oxycodone or any other drugs will be used in the study * preoperative opioids medication * opioids abuse * hepatic or renal dysfunction * cardiovascular or pulmonary dysfunction * lack of full civil capacity or refuse to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS scores | 6 hours after surgery | Postoperative pain will be evaluated on a 11point number rating scale (NRS): 0 means no pain; and 10 means worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NRS scores | 1, 24, 48 hours after surgery | Postoperative pain will be evaluated on a 11point number rating scale (NRS): 0 means no pain; and 10 means worst pain imaginable. |
| rescue analgesics usage | from the end of surgery to the first usage (up to 48 hours post-surgery) | time to the first use of rescue analgesics |
| PCIA pressing times | 48 hours after surgery | total pressing times and effective pressing times |
| anal exhaust time | from the end of surgery to the first anal exhaust (up to 48 hours post-surgery) | — |
| adverse events | within 48 hours after surgery | dizziness, drowsiness, nausea and vomiting, intestinal paralysis, skin itching, respiratory depression, intestinal obstruction, severe allergic reactions, and serious cardiovascular adverse events |
Countries
China
Contacts
Primary ContactSiyuan Liu, PhD
Outcome results
None listed