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Quadratus Lumborum Type 2 as Chronic Hip Pain Treatment

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ClinicalTrials.gov Identifier: NCT04438265
Recruitment Status : Recruiting
First Posted : June 18, 2020
Last Update Posted : September 30, 2022
Sponsor:
Collaborators:
Hospital Universitaio Getafe
Hospital Rio Hortega
Information provided by (Responsible Party):
María Teresa Fernandez, Hospital del Río Hortega

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
Hip Arthropathy Chronic Hip Pain Ultrasound Therapy; Complications Drug: levobupivacaine Device: ultrasound device

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Quadratus Lumborum Type 2 as Chronic Hip Pain Treatment
Actual Study Start Date : September 1, 2020
Actual Primary Completion Date : September 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort 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 Name: chirocane

Device: ultrasound device
scream

Control
Current analgesia , no QL block apply



Primary Outcome Measures :
  1. relieve chronic hip pain [ Time Frame: 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 [ Time Frame: 2 months ]
    find if there is complications (hematome, kidney punction...)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patient with coxarthrosis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04438265


Contacts
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Contact: Maria Teresa T Fernandez 637571685 maitefm70@hotmail.com
Contact: Maria Fernandez 637571685 maitefm70@hotmail.com

Locations
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Spain
María Teresa Fernandez Recruiting
Valladolid, Castilla Y León, Spain, 47008
Contact: María Teresa Fernandez    637571685    maitefm70@hotmail.com   
Sponsors and Collaborators
Hospital Medina del Campo
Hospital Universitaio Getafe
Hospital Rio Hortega
Investigators
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Study Chair: Maria Teresa Fernandez Hospital Medina del Campo
Publications:
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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: June 18, 2020    Key Record Dates
Last Update Posted: September 30, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Hospital del Río Hortega:
chronic hip pain
ultrasound therapy
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents