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NCT Number: NCT06690307

Oxycodone Versus Sufentanil 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.

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Key information

Conditions

Laparoscopic Hysterectomy

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Affiliated hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location status: Recruiting

Location contact

Wei Shi

CONTACT

[email protected]

0513-85052297

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

patient controlled intravenous analgesia(PCIA)

Procedure

Patients will receive sulfentanil for PCIA.

Primary outcomes

  1. NRS scores

    Time frame: 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 outcomes

  1. NRS scores

    Time frame: 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.

  2. rescue analgesics usage

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

    time to the first use of rescue analgesics

  3. PCIA pressing times

    Time frame: 48 hours after surgery

    total pressing times and effective pressing times

  4. anal exhaust time

    Time frame: from the end of surgery to the first anal exhaust (up to 48 hours post-surgery)

  5. adverse events

    Time frame: 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

  6. NRS scores

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Siyuan Liu, PhD

CONTACT

[email protected]

+86-85050301

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Official study title

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

Acronym: Oxycodone

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 15, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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