NCT05810571

Brief Summary

patients who will undergo elective open nephrectomy will be divided into three groups; the control (PCA), the erector spina plane block, and the quadratus lumborum block. After standard anesthesia induction and monitorization then Bispectral index monitoring will be applied to all patients. Anesthesia will be maintained using sevoflurane in a mixture of oxygen and air. Continuous remifentanil infusion will be used for analgesia. Then patient's numeric rating scales and morphine pca consumptions will be recorded for one day.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Progress72%
Oct 2024Jan 2027

First Submitted

Initial submission to the registry

March 31, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
1.5 years until next milestone

Study Start

First participant enrolled

October 24, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2027

Last Updated

October 26, 2024

Status Verified

September 1, 2024

Enrollment Period

2.2 years

First QC Date

March 31, 2023

Last Update Submit

October 24, 2024

Conditions

Renal Cell Carcinoma

Keywords

erector spina plane blockquadratus lumborum blockpatient controlled analgesianephrectomyanalgesia

Outcome Measures

Primary Outcomes (1)

  • postoperative morphine consumption

    amount of postoperative morphine use of the patient's

    24 hour postoperatively

Secondary Outcomes (2)

  • peroperative remifentanil consumptions

    4 hour preoperatively

  • numeric rating scale

    24 hour postoperatively

Study Arms (3)

patient controlled analgesia

PLACEBO COMPARATOR

this group of patients received no block, received only postoperative patient-controlled analgesia with morphine

Procedure: preoperative remifentanil consumptionProcedure: postopeartive controlled anlagesia with morphine

erector spina plane block

ACTIVE COMPARATOR

this group of patients received erector spina plane block preoperatively, received only postoperative patient-controlled analgesia with morphine

Procedure: preoperative remifentanil consumptionProcedure: postopeartive controlled anlagesia with morphine

quadratus lumborum block

ACTIVE COMPARATOR

this group of patients received erector spina plane block preoperatively, received only postoperative patient-controlled analgesia with morphine

Procedure: preoperative remifentanil consumptionProcedure: postopeartive controlled anlagesia with morphine

Interventions

preoperative remifentanil consumptionPROCEDURE

continuous remifentanil infusion will applied for peroperative analgesia

erector spina plane blockpatient controlled analgesiaquadratus lumborum block
postopeartive controlled anlagesia with morphinePROCEDURE

postoperative morphine patient controlled analgesia will be applied for postoperative analgesia

erector spina plane blockpatient controlled analgesiaquadratus lumborum block

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1-3
  • open nephrectomy elective patients
  • BMI\<35

You may not qualify if:

  • ASA 4-5-6
  • Laparoscopic nephrectomy
  • infection at the block side
  • coagulation disorder
  • BMI\>35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kocaeli University Medical Faculty

İzmit, 41100, Turkey (Türkiye)

RECRUITING

Kocaeli University Medical Faculty

Kocaeli, Turkey (Türkiye)

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal CellAgnosia

Interventions

Morphine

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Central Study Contacts

zehra ipek Arslan AYDIN, Professor

CONTACT

00905325011339zehraipek48@gmail.com

Zehra ipek Arslan, Professor

CONTACT

00905325011339zehraipek48@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
participant will not know which block applied, and the outcome assessor of the postoperative analgesia will not know
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 31, 2023

First Posted

April 12, 2023

Study Start

October 24, 2024

Primary Completion (Estimated)

January 3, 2027

Study Completion (Estimated)

January 3, 2027

Last Updated

October 26, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)