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

ConditionLaparoscopic Hysterectomy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorAffiliated Hospital of Nantong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

selective laparoscopic hysterectomy

general anesthesia

ASA classification I - III

aged 18 - 65 years

Disqualifiers

allergy to oxycodone or any other drugs will be used in the study

preoperative opioids medication

opioids abuse

hepatic or renal dysfunction

Trial design

Design model

Parallel

Treatments tested in this trial

  • patient controlled intravenous analgesia(PCIA)

    Procedure/Surgery

    Patients will receive sulfentanil for PCIA.

  • patient controlled intravenous analgesia(PCIA)

    Procedure/Surgery

    Patients will receive oxycodone for PCIA.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: sulfentanil groupActive comparator 1 intervention
Group B: oxycodone groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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)
3

PCIA pressing times

total pressing times and effective pressing times

Time frame
48 hours after surgery
4

anal exhaust time

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Affiliated Hospital of Nantong University

Lead sponsor

Source ClinicalTrials.gov
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