Oxycodone Versus Sufentanil in Patient-controlled Intravenous Analgesia After Laparoscopic Hysterectomy

Phase 4

Recruiting

• Conditions: Laparoscopic Hysterectomy

• Registration Number: NCT06690307
• Lead Sponsor: Affiliated Hospital of Nantong University

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.

Study Timeline

• Study First Submitted: 2024-11-09
• Study First Submitted QC: 2024-11-13
• Study First Posted: 2024-11-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Study Start: 2024-12-03
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-12-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
NRS scores	30 days 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

Trial Locations

Locations (1)

Affiliated hospital of Nantong University; 🇨🇳 Nantong, Jiangsu, China