NCT04438265

Brief Summary

The main objective of the study is to assess whether the performance of type 2 quadratus lumborum block produces an improvement in the quality of life of the patient with osteoarthritis of the hip.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

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
8 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

October 23, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

June 10, 2020

Last Update Submit

October 19, 2024

Conditions

Keywords

chronic hip painultrasound therapy

Outcome Measures

Primary Outcomes (1)

  • relieve chronic hip pain

    The main objective of the study is to assess whether the performance of type 2 lumbar .square block produces an improvement in the quality of life of the patient with osteoarthritis of the hip. The evaluation of the patient will consist of 2 stages. The first of these will consist of the evaluation consultation evaluation with verbal numeric scale (VNS: 0 no dolor-10 the worst pain imaginable ) if patients improve their quality of pain

    3 months

Secondary Outcomes (1)

  • rate of adverse effects of the block

    3 months

Other Outcomes (1)

  • relieve chronic pain at 6 month

    6 months

Study Arms (2)

quadratus lumborum

analgesic technique. The evaluation of the patient will consist of 2 stages. The first of these will consist of the evaluation consultation (clinical history, EVN evaluation, WOMAC) and initial treatment (QL2 block). In the second stage, the patient will be followed up with interviews at 3 weeks, 3 and 6 months.

Drug: levobupivacaineDevice: ultrasound device

Control

Current analgesia , no QL block apply

Interventions

local anesthetic

Also known as: chirocane
quadratus lumborum

scream

quadratus lumborum

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patient with coxalgia

You may qualify if:

  • Sign informed consent (Annex 2)
  • Age 18-85 years
  • Cartilage injury (coxarthrosis) hip
  • Illness \<1 year of evolution
  • Patients with pain after treatment with physical therapy, exercises, NSAIDs.
  • EVN\> 5

You may not qualify if:

  • Refusal of the patient
  • Allergy to the drugs used
  • Contraindication for performing the technique
  • Intraarticular treatment in the previous 3 months
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

María Teresa Fernandez

Valladolid, Castille and León, 47008, Spain

Location

Related Publications (5)

  • Adhikary SD, Short AJ, El-Boghdadly K, Abdelmalak MJ, Chin KJ. Transmuscular quadratus lumborum versus lumbar plexus block for total hip arthroplasty: A retrospective propensity score matched cohort study. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):372-378. doi: 10.4103/joacp.JOACP_335_17.

    PMID: 30386022BACKGROUND
  • Adhikary SD, El-Boghdadly K, Nasralah Z, Sarwani N, Nixon AM, Chin KJ. A radiologic and anatomic assessment of injectate spread following transmuscular quadratus lumborum block in cadavers. Anaesthesia. 2017 Jan;72(1):73-79. doi: 10.1111/anae.13647. Epub 2016 Oct 12.

    PMID: 27730633BACKGROUND
  • Fernandez Martin MT, Lopez Alvarez S, Ortigosa Solorzano E. Quadratus lumborum block. New approach for a chronic hip pain. Cases report. Rev Esp Anestesiol Reanim (Engl Ed). 2020 Jan;67(1):44-48. doi: 10.1016/j.redar.2019.10.001. Epub 2019 Nov 22. English, Spanish.

    PMID: 31767198BACKGROUND
  • Fernandez MT, Aguirre JA, Lopez S. Posterior Quadratus Lumborum Block, A Novel Approach to Treat Chronic Hip Pain: A Case Series. A A Pract. 2023 Mar 17;17(3):e01671. doi: 10.1213/XAA.0000000000001671. eCollection 2023 Mar 1.

    PMID: 36930793BACKGROUND
  • Fernandez Martin MT, Ortigosa E, Aguirre JA. Posterior quadratus lumborum block in chronic hip pain, preliminary results from a prospective study. Minerva Anestesiol. 2023 Mar;89(3):231-233. doi: 10.23736/S0375-9393.22.16892-6. Epub 2022 Oct 25. No abstract available.

MeSH Terms

Interventions

LevobupivacaineUltrasonography

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

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 18, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2022

Study Completion

June 1, 2024

Last Updated

October 23, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations