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

Affiliated Hospital of Nantong University

Status and phase: Enrolling; Phase 4

Conditions: Laparoscopic Hysterectomy

Treatments: Procedure: patient controlled intravenous analgesia(PCIA)

Study type: Interventional

Funder types: Other

Identifiers

NCT06690307

2024-K115-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups

sulfentanil group

Active Comparator group

Description:

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

Treatment:

Procedure: patient controlled intravenous analgesia(PCIA)

Procedure: patient controlled intravenous analgesia(PCIA)

oxycodone group

Experimental group

Description:

Participants in the experimental group will receive oxycodone for PCIA.

Treatment:

Procedure: patient controlled intravenous analgesia(PCIA)

Procedure: patient controlled intravenous analgesia(PCIA)