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

NCT06690307 | Recruiting Phase 4

• 1 other identifier: 2024-K115-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Hysterectomy

Keywords

oxycodone; patient-controlled intravenous analgesia; laparoscopic hysterectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• NRS scores

  1, 24, 48 hours after surgery

• rescue analgesics usage

  from the end of surgery to the first usage (up to 48 hours post-surgery)

• PCIA 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

  within 48 hours after surgery

Study Arms (2)

sulfentanil group

ACTIVE COMPARATOR

Participants in the active comparator group will receive sulfentanil for PCIA.

Procedure: patient controlled intravenous analgesia(PCIA)

oxycodone group

EXPERIMENTAL

Participants in the experimental group will receive oxycodone for PCIA.

Procedure: patient controlled intravenous analgesia(PCIA)

Interventions

patient controlled intravenous analgesia(PCIA) PROCEDURE

Patients will receive sulfentanil for PCIA.

sulfentanil group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• selective laparoscopic hysterectomy
• general anesthesia
• ASA classification I - III
• aged 18 - 65 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated hospital of Nantong University

Nantong, Jiangsu, 226001, China

RECRUITING

Central Study Contacts

Siyuan Liu, PhD

CONTACT

+86-85050301; tdfylsy@ntu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 9, 2024
• First Posted: November 15, 2024
• Study Start: December 3, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

CN (1)