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

NCT ID: NCT06690307

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-03

Study Completion Date

2026-07-31

Brief Summary

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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

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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.

Conditions

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Laparoscopic Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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sulfentanil group

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

Group Type ACTIVE_COMPARATOR

patient controlled intravenous analgesia(PCIA)

Intervention Type PROCEDURE

Patients will receive sulfentanil for PCIA.

oxycodone group

Participants in the experimental group will receive oxycodone for PCIA.

Group Type EXPERIMENTAL

patient controlled intravenous analgesia(PCIA)

Intervention Type PROCEDURE

Patients will receive oxycodone for PCIA.

Interventions

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patient controlled intravenous analgesia(PCIA)

Patients will receive sulfentanil for PCIA.

Intervention Type PROCEDURE

patient controlled intravenous analgesia(PCIA)

Patients will receive oxycodone for PCIA.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital of Nantong University

OTHER

Sponsor Role lead

Responsible Party

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Siyuan Liu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Affiliated hospital of Nantong University

Nantong, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Siyuan Liu, PhD

Role: CONTACT

+86-85050301

Facility Contacts

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Wei Shi

Role: primary

0513-85052297

Other Identifiers

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2024-K115-01

Identifier Type: -

Identifier Source: org_study_id