A Phase 4 interventional study of patient controlled intravenous analgesia(PCIA) and patient controlled intravenous analgesia(PCIA) in Laparoscopic Hysterectomy, sponsored by Affiliated Hospital of Nantong University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Affiliated Hospital of Nantong University · Phase 4, Interventional, and Treatment
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.
Affiliated Hospital of Nantong University is the lead sponsor of 92 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in the active comparator group will receive sulfentanil for PCIA.
Procedure: patient controlled intravenous analgesia(PCIA)
Participants in the experimental group will receive oxycodone for PCIA.
Procedure: patient controlled intravenous analgesia(PCIA)
Patients will receive sulfentanil for PCIA.
Patients will receive oxycodone for PCIA.
NRS scores
Postoperative pain will be evaluated on a 11point number rating scale (NRS): 0 means no pain; and 10 means worst pain imaginable.
Time frame: 6 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.
Time frame: 1, 24, 48 hours after surgery
rescue analgesics usage
time to the first use of rescue analgesics
Time frame: 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
Time frame: 48 hours after surgery
anal exhaust time
Time frame: 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
Time frame: 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.
Time frame: 30 days after surgery
Plan to share: Undecided
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Affiliated Hospital of Nantong University