Hip ArthropathyNCT04438265
Quadratus Lumborum Type 2 as Chronic Hip Pain Treatment
An observational study of Hip Arthropathy and Chronic Hip Pain, run by Hospital Medina del Campo at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hip Arthropathy, Chronic Hip Pain, Ultrasound Therapy; Complications
- What is being tested?
- levobupivacaine and ultrasound device
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with coxalgia
Who may be able to join
- 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
Who cannot join
- Refusal of the patient
- Allergy to the drugs used
- Contraindication for performing the technique
- Intraarticular treatment in the previous 3 months
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The quadratus lumborum 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 quadratus lumborum 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 or posterior, 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.
- Being tested
- levobupivacaine, ultrasound device
- Keywords
- chronic hip pain, ultrasound therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levobupivacaineDrug
Also called chirocane
local anesthetic
ultrasound deviceDevice
scream
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: levobupivacaine; Device: ultrasound device | |
| Control | Current analgesia , no QL block apply |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
rate of adverse effects of the block
find if there is complications (hematome, kidney punction...)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start1 Sep 2020
- Primary completion1 Sep 2022
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hip ArthropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Medina del Campo
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitaio Getafe, Hospital Rio Hortega
- Responsible party
- Principal investigator, María Teresa Fernandez, Hospital del Rio Hortega
- Investigators
- Maria Teresa Fernandez, Study chair, Hospital Medina del Campo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438265
- Sponsor's protocol ID
- PI20-1770 A.4.2/PI 21-PI104
- Status last verified
- Oct 2024
- First submitted
- 10 Jun 2020
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30386022Adhikary 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.
PubMed 27730633Fernandez 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.
PubMed 31767198Fernandez 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.
PubMed 36930793Fernandez 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.
PubMed 36282230Fernandez Martin MT, Aguado-Maestro I, Aguirre JA. Posterior quadratus lumborum block, a novel approach to treat chronic hip pain: a cohort study. Minerva Anestesiol. 2025 Sep;91(9):800-807. doi: 10.23736/S0375-9393.25.18749-X. Epub 2025 Apr 11.
PubMed 40214220
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Type 2 as Chronic Hip Pain Treatment
- ClinicalTrials.gov ID
- NCT04438265
- Acronym / sponsor ID
- PI20-1770 A.4.2/PI 21-PI104
- Keywords
- chronic hip pain, ultrasound therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospital Medina del CampoUniversity, hospital or other
- Collaborators
- Hospital Universitaio Getafe, Hospital Rio Hortega
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 quadratus lumborum 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 quadratus lumborum 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 or posterior, 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| quadratus lumborum | – | Drug: levobupivacaine, Device: ultrasound deviceanalgesic 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. |
| Control | – | –Current analgesia , no QL block apply |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with coxalgia
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- Refusal of the patient
- Allergy to the drugs used
- Contraindication for performing the technique
- Intraarticular treatment in the previous 3 months
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levobupivacaineAlso: chirocanelocal anesthetic | Drug | quadratus lumborum |
| ultrasound devicescream | Device | quadratus lumborum |
Primary outcome
relieve chronic hip pain
Time frame: 3 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
1 secondary outcome
rate of adverse effects of the block
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Background: PubMed 30386022Adhikary 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.
- Background: PubMed 27730633Adhikary 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.
- Background: PubMed 31767198Fernandez 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.
- Background: PubMed 36930793Fernandez 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.
- Results publication: PubMed 36282230Fernandez 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.
- Derived from this study: PubMed 40214220Fernandez Martin MT, Aguado-Maestro I, Aguirre JA. Posterior quadratus lumborum block, a novel approach to treat chronic hip pain: a cohort study. Minerva Anestesiol. 2025 Sep;91(9):800-807. doi: 10.23736/S0375-9393.25.18749-X. Epub 2025 Apr 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Teresa Fernandez study chair
Hospital Medina del Campo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Arthropathy and Chronic Hip Pain, run by Hospital Medina del Campo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relieve chronic hip pain (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04438265, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.