Total Hip ArthroplastyQLB-3NCT04555291
Analgesic Effect of the QLB-3 for Patients Undergoing a Total Hip Surgery
A study testing Ropivacaine injection and NACL in people with Total Hip Arthroplasty, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
Total hip arthroplasty (THA) is one of the main elective orthopedic surgery. Recent studies have proven that patients undergoing an elective THA who are part of a fast track surgery program including an opioid free anesthesia (OFA) presented a decrease of mortality and a reduced in-hospital length of stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Ropivacaine injection and NACL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Jan 2022to 10 Oct 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients with unilateral programmed total hip prosthesis surgery are included in the absence of inclusion criteria.
- Obligation for all patients to be affiliated with social security
- Patient Informed Consent Signature
Who cannot join
- chronic opiod consumption
- pregnancy
- mental disorder that prevents the usage of the numeric analog scale
- Contra indications of the realization of QLB
- Local infection
- Allergic to the local anesthesia
- Hemostasis disorder
- Incapacity of giving the consent : individuals under guardianship by court order, or under judicial protection
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de nice - Anesthésie Réanimation
Nice, Alpes-Maritimes, 06001
Institut Arnaut Tzanck
Nice, Alpes-Maritimes, 06700
About this study
Official title: Analgesic Efficiency of the Type 3 Quadratum Lumborum Block in Patients Undergoing Total Hip Arthroplasty : a Randomized Double Blinded Trial
Total hip arthroplasty (THA) is one of the main elective orthopedic surgery. Recent studies have proven that patients undergoing an elective THA who are part of a fast track surgery program including an opioid free anesthesia (OFA) presented a decrease of mortality and a reduced in-hospital length of stay. Based on the anatomical knowledges, the Quadratus Lumborum Block seems to be an interesting locoregional technique for patients undergoing THA. So far, there is no recommanded locoregional aesthesia in this indication. The investigators hypothezised that QLB would give an efficient analgesia in the 24h following a THA.
Therefor, the study performed a prospective, randomized, double blind trial in the Nice Universitary hospital of Pasteur 2 and in Arnault Tzanck Institute among all patients who underwent THA, comparing a QLB using ropivacaïne 2mg/ml 20ml vs isotonic saline solution 20 ml.The main end-point is the decrease opiod consumption in the 24h following THA.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Ropivacaine injection, NACL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine injectionDrug
Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of ropivacaïne 2 mg/ml
NACLOther
Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of NACL
| Study group | Role | What they receive |
|---|---|---|
| Drug Ropivacaïne 2 mg/ml | Experimental | Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of ropivacaïne 2 mg/ml Receives: Drug: Ropivacaine injection |
| NACL | Placebo comparator | Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of NACL Receives: Other: NACL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opoïd consumption
The main end point of this study is the decrease of opiod consumption in the 24h following THA.
Measured: At 24 Hours
Secondary outcomes (1)
morphine equivalent dose
following surgery at rest and in motion
Measured: At 48 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start5 Jan 2022
- Primary completion6 Oct 2023
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rozier Romain, Principal investigator, Anesthésie Réanimation - CHU de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555291
- Sponsor's protocol ID
- 19-PP-13
- Acronym
- QLB-3
- Status last verified
- Mar 2026
- First submitted
- 11 Aug 2020
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rozier R, Loiseleur A, Ciais C, Moulin O, Alais B, Marguerite K, Badia E, Tran L, Balbo J, Maurice-Szamburski A. Anterior quadratus lumborum block in total hip arthroplasty: a two-center, randomized, placebo-controlled trial showing no additional benefit over multimodal analgesia. Reg Anesth Pain Med. 2026 May 5;51(5):491-497. doi: 10.1136/rapm-2024-106247.
PubMed 39929638
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficiency of the Type 3 Quadratum Lumborum Block in Patients Undergoing Total Hip Arthroplasty : a Randomized Double Blinded Trial
- ClinicalTrials.gov ID
- NCT04555291
- Acronym / sponsor ID
- QLB-3 / 19-PP-13
- Conditions
- Total Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 18 Sep 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.
Total hip arthroplasty (THA) is one of the main elective orthopedic surgery. Recent studies have proven that patients undergoing an elective THA who are part of a fast track surgery program including an opioid free anesthesia (OFA) presented a decrease of mortality and a reduced in-hospital length of stay. Based on the anatomical knowledges, the Quadratus Lumborum Block seems to be an interesting locoregional technique for patients undergoing THA. So far, there is no recommanded locoregional aesthesia in this indication. The investigators hypothezised that QLB would give an efficient analgesia in the 24h following a THA.
Therefor, the study performed a prospective, randomized, double blind trial in the Nice Universitary hospital of Pasteur 2 and in Arnault Tzanck Institute among all patients who underwent THA, comparing a QLB using ropivacaïne 2mg/ml 20ml vs isotonic saline solution 20 ml.The main end-point is the decrease opiod consumption in the 24h following THA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Ropivacaïne 2 mg/ml | Experimental | Drug: Ropivacaine injectionRealization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of ropivacaïne 2 mg/ml |
| NACL | Placebo comparator | Other: NACLRealization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of NACL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All adult patients with unilateral programmed total hip prosthesis surgery are included in the absence of inclusion criteria.
- Obligation for all patients to be affiliated with social security
- Patient Informed Consent Signature
Key exclusion criteria (8 listed)
- chronic opiod consumption
- pregnancy
- mental disorder that prevents the usage of the numeric analog scale
- Contra indications of the realization of QLB
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 |
|---|---|---|
| Ropivacaine injectionRealization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of ropivacaïne 2 mg/ml | Drug | Drug Ropivacaïne 2 mg/ml |
| NACLRealization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of NACL | Other | NACL |
Primary outcome
Opoïd consumption
Time frame: At 24 Hours
The main end point of this study is the decrease of opiod consumption in the 24h following THA.
1 secondary outcome
morphine equivalent dose
Time frame: At 48 Hours
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 24 Mar 2026.
- Results publication: PubMed 39929638Rozier R, Loiseleur A, Ciais C, Moulin O, Alais B, Marguerite K, Badia E, Tran L, Balbo J, Maurice-Szamburski A. Anterior quadratus lumborum block in total hip arthroplasty: a two-center, randomized, placebo-controlled trial showing no additional benefit over multimodal analgesia. Reg Anesth Pain Med. 2026 May 5;51(5):491-497. doi: 10.1136/rapm-2024-106247.
- Individual participant dataSharing planned: No
Related trials for Total Hip Arthroplasty
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
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Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator
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Not yet recruiting
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty
Total Hip Arthroplasty (THA)
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.
Rozier Romain principal investigator
Anesthésie Réanimation - CHU de Nice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine injection and NACL in people with Total Hip Arthroplasty, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
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 3 inclusion and 8 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 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. Some participants in this study may receive a placebo. 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?
Opoïd consumption (time frame: At 24 Hours). 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 NCT04555291, which also lists 1 linked publication.
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 24 Mar 2026.