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

The Efficacy and Safety of Oxycodone in Patient-controlled Intravenous Analgesia After Laparoscopic Hysterectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Laparoscopic Hysterectomy
• Intervention / Treatment: Procedure: patient controlled intravenous analgesia(PCIA); Procedure: patient controlled intravenous analgesia(PCIA)

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 Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Siyuan Liu, PhD; Phone Number: +86-85050301; Email: tdfylsy@ntu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 226001
      • Recruiting
      • Affiliated Hospital of Nantong University
      • Contact: Wei Shi; Phone Number: 0513-85052297; Email: jsrdwbb@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: sulfentanil group; Participants in the active comparator group will receive sulfentanil for PCIA.	Procedure: patient controlled intravenous analgesia(PCIA); Patients will receive sulfentanil for PCIA.; Procedure: patient controlled intravenous analgesia(PCIA); Patients will receive oxycodone for PCIA.
Experimental: oxycodone group; Participants in the experimental group will receive oxycodone for PCIA.	Procedure: patient controlled intravenous analgesia(PCIA); Patients will receive sulfentanil for PCIA.; Procedure: patient controlled intravenous analgesia(PCIA); Patients will receive oxycodone for PCIA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: November 9, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: oxycodone; laparoscopic hysterectomy; patient-controlled intravenous analgesia
• Other Study ID Numbers: 2024-K115-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No