Quadratus Lumborum Type 2 as Chronic Hip Pain Treatment

Sponsor
Hospital Medina del Campo (Other)
Overall Status
Recruiting
CT.gov ID
NCT04438265
Collaborator
(none)
100
1
27
3.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Detailed Description

The lumbar square block is an interfascial block of the posterior wall of the abdomen, initially described for the management of postoperative pain in abdominal surgery due to its suggested effect on the T7-11 roots. The analgesic efficacy of type 1 lumbar square block (QL1) in hip surgery was subsequently published. Regarding chronic pain, QL2 has been successfully performed in posttherniorrhaphy pain or pancreatic cancer.

This quadratus lumborum type 2 is performed in the patients with hip joint based on the innervation of the hip and taking the role of thoraco-lumbar fascia in the analgesia of these patients as a reference. The good results obtained in the first 5 patients have led us to evaluate whether this blockade can indeed be an analgesic alternative in patients with coxarthrosis.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Quadratus Lumborum Type 2 as Chronic Hip Pain Treatment
Actual Study Start Date :
Sep 1, 2020
Actual Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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: levobupivacaine
local anesthetic
Other Names:
  • chirocane
  • Device: ultrasound device
    scream

    Outcome Measures

    Primary Outcome Measures

    1. relieve chronic hip pain [2 months]

      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

    Secondary Outcome Measures

    1. rate of adverse effects of the block [2 months]

      find if there is complications (hematome, kidney punction...)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • Refusal of the patient

    • Allergy to the drugs used

    • Contraindication for performing the technique

    • Intraarticular treatment in the previous 3 months

    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 María Teresa Fernandez Valladolid Castilla Y León Spain 47008

    Sponsors and Collaborators

    • Hospital Medina del Campo

    Investigators

    • Study Chair: Maria Teresa Fernandez, Hospital Medina del Campo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    María Teresa Fernandez, Principal Investigator, Hospital del Río Hortega
    ClinicalTrials.gov Identifier:
    NCT04438265
    Other Study ID Numbers:
    • PI20-1770 A.4.2
    First Posted:
    Jun 18, 2020
    Last Update Posted:
    Aug 2, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by María Teresa Fernandez, Principal Investigator, Hospital del Río Hortega
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 2, 2022