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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

Tracking Information
First Submitted Date June 10, 2020
First Posted Date June 18, 2020
Last Update Posted Date September 30, 2022
Actual Study Start Date September 1, 2020
Actual Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 18, 2020)
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
Original Primary Outcome Measures
 (submitted: June 17, 2020)
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) if patients improve their quality of pain
Change History
Current Secondary Outcome Measures
 (submitted: June 18, 2020)
rate of adverse effects of the block [ Time Frame: 2 months ]
find if there is complications (hematome, kidney punction...)
Original Secondary Outcome Measures
 (submitted: June 17, 2020)
assess adverse effects of the block [ Time Frame: 2 months ]
find if there is complications (hematome, kidney punction...)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quadratus Lumborum Type 2 as Chronic Hip Pain Treatment
Official Title Quadratus Lumborum Type 2 as Chronic Hip Pain Treatment
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.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patient with coxarthrosis
Condition
  • Hip Arthropathy
  • Chronic Hip Pain
  • Ultrasound Therapy; Complications
Intervention
  • Drug: levobupivacaine
    local anesthetic
    Other Name: chirocane
  • Device: ultrasound device
    scream
Study Groups/Cohorts
  • 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.
    Interventions:
    • Drug: levobupivacaine
    • Device: ultrasound device
  • Control
    Current analgesia , no QL block apply
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 17, 2020)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2022
Actual Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Maria Teresa T Fernandez 637571685 maitefm70@hotmail.com
Contact: Maria Fernandez 637571685 maitefm70@hotmail.com
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04438265
Other Study ID Numbers PI20-1770 A.4.2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party María Teresa Fernandez, Hospital del Río Hortega
Original Responsible Party María Teresa Fernandez, Hospital Medina del Campo, Principal Investigator
Current Study Sponsor Hospital Medina del Campo
Original Study Sponsor Same as current
Collaborators
  • Hospital Universitaio Getafe
  • Hospital Rio Hortega
Investigators
Study Chair: Maria Teresa Fernandez Hospital Medina del Campo
PRS Account Hospital Medina del Campo
Verification Date September 2022