NCT04431388

Brief Summary

Performing the nephrectomy by laparoscopy has decrease the incidence of postoperative pain, but there are still some patients who describe a severe pain after this surgery. Regional techniques allow a better recovery quality and adequate- managed pain control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

June 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

June 10, 2020

Last Update Submit

March 5, 2024

Conditions

Kidney Injury

Keywords

postoperative analgesiafascial blocksnephectomy

Outcome Measures

Primary Outcomes (2)

  • pain control and quality life.Numeric rating scale (NRS)

    To assess whether SIPB is superior in pain control

    "24 postoperative hours"

  • QoR15

    Postoperative quality recovery

    "24hours"

Secondary Outcomes (2)

  • Opioids consumption

    "48 hours"

  • Side effects

    "24hours"

Other Outcomes (1)

  • control

    "24 hours"

Study Arms (3)

SIPB (block)

Patients undergone nephectomy and who received SIPB as analgesia

Device: ultrasound deviceDrug: Levobupivacaine

QL block

Patients undergone nephectomy and who received QL as analgesia

Device: ultrasound deviceDrug: Levobupivacaine

control

Patients undergone nephrectomy who didn´t receive regional anesthesia

Interventions

ultrasound deviceDEVICE

We performe a differnt analgesic techniques to know if some of then are better

Also known as: device
QL blockSIPB (block)
LevobupivacaineDRUG

using the same AL

Also known as: drug
QL blockSIPB (block)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A sample size of 80 patients (40 in each group) has been calculated assuming that we intend to confirm a 15% improvement in pain control and postoperative recovery in the serratus-intercostal plane block group.

You may qualify if:

  • signature of informed consent
  • age \> 18 years
  • ASA risk scale \< IV
  • Scheduled to nephrectomy.

You may not qualify if:

  • Patients with cognitive impairment or inability to sign informed consent,
  • Refused to participate
  • Hypersensitivity to the drugs used
  • contraindication of regional technique (coagulopathy, infection)
  • history of chronic pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

María Teresa Fernandez

Valladolid, VA, 47008, Spain

Location

Related Publications (4)

  • Corso RM, Piraccini E, Sorbello M, Bellantonio D, Tedesco M. Ultrasound-guided transmuscular quadratus lumborum block for perioperative analgesia in open nephrectomy. Minerva Anestesiol. 2017 Dec;83(12):1334-1335. doi: 10.23736/S0375-9393.17.12167-X. Epub 2017 Jul 5. No abstract available.

    PMID: 28679202BACKGROUND

  • Corso RM, Piraccini E, Sorbello M, Bellantonio D, Tedesco M. Transmuscular quadratus lumborum block versus serratus-intercostal interfascial plane block: the game has just begun. Minerva Anestesiol. 2018 Jul;84(7):873-874. doi: 10.23736/S0375-9393.18.12849-5. Epub 2018 Mar 27. No abstract available.

    PMID: 29589427BACKGROUND

  • Fernandez Martin MT, Lopez Alvarez S, Fajardo Perez M, Perez Herrero M. Serratus-intercostal interfascial plane block: alternative analgesia for open nephrectomy? Minerva Anestesiol. 2018 Jul;84(7):872-873. doi: 10.23736/S0375-9393.18.12808-2. Epub 2018 Feb 22. No abstract available.

    PMID: 29479932BACKGROUND

  • Fernandez Martin MT, Lopez Alvarez S, Perez Herrero MA. Serratus-intercostal interfascial block as an opioid-saving strategy in supra-umbilical open surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Oct;65(8):456-460. doi: 10.1016/j.redar.2018.03.007. Epub 2018 May 20. English, Spanish.

    PMID: 29789137BACKGROUND

MeSH Terms

Interventions

UltrasonographyEquipment and SuppliesLevobupivacainePharmaceutical Preparations

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisBupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Maria Teresa Fernandez

    Hospital Medina del Campo

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 16, 2020

Study Start

June 1, 2021

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

March 7, 2024

Record last verified: 2024-03

Locations

ES(1)