NCT03685188

Brief Summary

We design this randomized controlled trial to compare the safety and efficacy of Oxycodone and Sufentanil for postoperative patient-controlled analgesia in patients undergoing hip surgery, with a view to finding the optimal postoperative analgesic regime with fewer adverse reactions and promoting patients' rehabilitation.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
570

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

6.1 years

First QC Date

September 13, 2018

Last Update Submit

October 4, 2024

Conditions

Analgesia, Patient-Controlled

Keywords

Randomized controlled trialoxycodonesufentanilpatient-controlled intravenous analgesiahip surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative numerical rating scales (NRS) at rest

    Resting NRS pain scores at 2 h after surgery.

    Up to 72 hours after operation

Secondary Outcomes (16)

  • Incidence of post operative nausea and vomiting (PONV)

    Up to 72 hours after operation

  • The severity of first PONV and the most severe PONV

    Up to 30 days after operation

  • Time from the end of operation to the first onset of PONV

    Up to 30 days after operation

  • Postoperative numerical rating scales (NRS) at rest

    Up to 72 hours after operation

  • Postoperative NRS on movement

    Up to 72 hours after operation

  • +11 more secondary outcomes

Study Arms (2)

Oxycodone group

EXPERIMENTAL

PCIA is formulated at 0.4 mg/ml of oxycodone.

Drug: Oxycodone Hydrochloride

Sufentanil group

ACTIVE COMPARATOR

PCIA is formulated at 2 μg/ml of sufentanil.

Drug: Sufentanil Citrate

Interventions

Oxycodone HydrochlorideDRUG

Subjects will receive patient' controlled intravenous analgesia in analgesic pump with 0.4 mg/ml of oxycodone for postoperative analgesia.

Oxycodone group
Sufentanil CitrateDRUG

Subjects will receive patient' controlled intravenous analgesia in analgesic pump with 2 μg/ml of sufentanil for postoperative analgesia.

Sufentanil group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing unilateral hip surgery, sign the "informed consent form".
  • Age above 18 years old, with both genders.

You may not qualify if:

  • Pregnant or lactating women.
  • Patient with history of drug abuse, including but not limited to opioids, amphetamines, ketamine, etc.
  • Allergic to opioids or any other anesthetic agent.
  • History or family history of malignant hyperthermia.
  • Have history of nervous system diseases such as peripheral neuropathy, psychiatric mental illness, or postoperative delirium.
  • Other conditions that the investigators consider unsuitable for participation in the study, such as Parkinson's disease, unable to communicate, or impairment of cognitive function etc.
  • Participation in another trial in the past three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

  • Liao C, Zhu H, Zhong J, Lai X, Zhang B, Liao R. Patient Controlled Intravenous Analgesia with Oxycodone or Sufentanil After Hip Surgery: Study Protocol for a Multi-Centered, Randomized Controlled Trial. J Clin Med. 2025 Feb 25;14(5):1525. doi: 10.3390/jcm14051525.

    PMID: 40095065DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

OxycodoneSufentanil

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsFentanylPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Ren Liao, M.D

    West China Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 13, 2018

First Posted

September 26, 2018

Study Start

December 1, 2018

Primary Completion

December 31, 2024

Study Completion

July 31, 2025

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)