Quadratus Lumborum Type 2 as Chronic Hip Pain Treatment

• ClinicalTrials.gov Identifier: NCT04438265
• Recruitment Status: Recruiting
• First Posted: June 18, 2020
• Last Update Posted: September 30, 2022
• Sponsor: Hospital Medina del Campo
• 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

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 *

• 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.
• 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.
• 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.

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

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