Oxycodone Versus Sufentanil in Patient-controlled Intravenous Analgesia After Laparoscopic Hysterectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: patient controlled intravenous analgesia(PCIA), patient controlled intravenous analgesia(PCIA).
- Who it may be relevant to
- Registry conditions: Laparoscopic Hysterectomy. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Efficacy and Safety of Oxycodone in Patient-controlled Intravenous Analgesia After Laparoscopic Hysterectomy
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.
Detailed 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.
Interventions
- Procedure patient controlled intravenous analgesia(PCIA)
Patients will receive sulfentanil for PCIA. - Procedure patient controlled intravenous analgesia(PCIA)
Patients will receive oxycodone for PCIA.
Primary outcome measures
- NRS scores [Time frame: 6 hours after surgery]
Secondary outcome measures (6)
- NRS scores [Time frame: 1, 24, 48 hours after surgery]
- rescue analgesics usage [Time frame: from the end of surgery to the first usage (up to 48 hours post-surgery)]
- PCIA 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 [Time frame: within 48 hours after surgery]
- NRS scores [Time frame: 30 days after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Affiliated hospital of Nantong University — Nantong
Identifiers
NCT: NCT06690307 · 2024-K115-01