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

Phase 4RecruitingNCT06690307

Affiliated Hospital of Nantong University64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Laparoscopic Hysterectomy

Interventions

patient controlled intravenous analgesia(PCIA)PROCEDURE

Patients will receive sulfentanil for PCIA.

patient controlled intravenous analgesia(PCIA)PROCEDURE

Patients will receive oxycodone for PCIA.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Affiliated hospital of Nantong University

Nantong, Jiangsu, China

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Siyuan Liu, PhD

CONTACT

+86-85050301 tdfylsy@ntu.edu.cn

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.