NCT03529201

Brief Summary

Oxycodone consumption and postoperative pain intensity in patients undergoing nephrectomy procedures. Of all study participants, 50% will obtain quadratus lumborum block (QLB).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

May 7, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2019

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

May 1, 2018

Last Update Submit

November 22, 2023

Conditions

Pain, PostoperativeChronic Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Total consumption of oxycodone

    Overall use of oxycodone administered by PCA pump will be assessed.

    24 hours after the end of surgery.

Secondary Outcomes (2)

  • Pain intensity

    24 hours after the end of surgery

  • Chronic pain

    6 months after the surgery

Study Arms (2)

QLB

EXPERIMENTAL

At the end of surgery, QLB with ropivacaine will be done on the side of the operation.

Procedure: QLBDevice: PCAProcedure: GADrug: OxycodoneDrug: SevofluraneDrug: FentanylDrug: Rocuronium

Control

EXPERIMENTAL

Standard care. No regional blocks.

Device: PCAProcedure: GADrug: OxycodoneDrug: SevofluraneDrug: FentanylDrug: Rocuronium

Interventions

QLBPROCEDURE

On the side of the surgery, QLB with 0.375% ropivacaine (0.2 mL/kg)

QLB
PCADEVICE

Patient-controlled analgesia

ControlQLB
GAPROCEDURE

General anesthesia

ControlQLB
OxycodoneDRUG

administered by PCA

ControlQLB
SevofluraneDRUG

Inhalational anesthetic during GA

ControlQLB
FentanylDRUG

painkiller during GA

ControlQLB
RocuroniumDRUG

muscle relaxant during GA

ControlQLB

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • obtained consent
  • nephrectomy procedure

You may not qualify if:

  • coagulopathy allergy to local anesthetics depression, antidepressant drugs treatment epilepsy usage of painkiller before surgery addiction to alcohol or recreational drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Anesthesiology and Intensive Care, J. Śniadecki Hospital in Białystok

Bialystok, 15-950, Poland

Location

Department of Anesthesiology and Intensive Care, F. Chopin Hospital in Rzeszów

Rzeszów, 35-055, Poland

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Passive Cutaneous AnaphylaxisOxycodoneSevofluraneFentanylRocuronium

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Skin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic TechniquesAntigen-Antibody ReactionsImmune System PhenomenaCodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsMethyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPiperidinesHeterocyclic Compounds, 1-RingAndrostanolsAndrostanesSteroidsFused-Ring Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
A regional block will be performed under general anesthesia. Patients will not be aware of this procedure.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomly allocated to one of the study arms: QLB or control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

May 1, 2018

First Posted

May 18, 2018

Study Start

May 7, 2018

Primary Completion

February 28, 2019

Study Completion

August 25, 2019

Last Updated

November 24, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

PL(2)