Pain, PostoperativePhase 4NCT04481451
Quadratus Lumborum vs Erector Spinae Supplementary Blocks With Lumbar Plexus Blocks for Hip PAO
A Phase 4 study testing Erector spinae block with ropivacaine 0.2%, Quadratus lumborum block with ropivacaine 0.2% and Ropivacaine in people with Pain, Postoperative and Regional Anesthesia, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This study proposes to evaluate the efficacy of single shot erector spinae block (ESB) versus single shot quadratus lumborum block (QLB) when used in conjunction with continuous lumbar plexus block (LPB) for postoperative analgesia in children and adolescents undergoing unilateral hip surgical procedures. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Regional Anesthesia, Hip Dysplasia
- What is being tested?
- Erector spinae block with ropivacaine 0.2%, Quadratus lumborum block with ropivacaine 0.2% and Ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 1 Dec 2025
- Phase
- Phase 4
- 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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- ASA I - III status, undergoing unilateral periacetabular osteotomy for treating primary diagnosis of developmental acetabular dysplasia in symptomatic young patients.
- Ages 15 - 30 years
Who cannot join
- Patients undergoing procedures including revision PAO, bilateral PAO, conversion to total hip arthroplasty.
- Patients whom for any reason did not received a lumbar plexus catheter as part of the baseline regional anesthesia plan
- Patients with body mass index (BMI) > 35
- Patients with known coagulopathies.
- Patients with severe neurodevelopmental delays.
- Patients with previous chronic pain syndromes.
- Patients with a history of opioid treatment at any point in the 2 months prior to surgery.
- Lack of parental consent and/or patient assent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children"S Hospital
Boston, Massachusetts, 02118
About this study
This study proposes to evaluate the efficacy of single shot erector spinae block (ESB) versus single shot quadratus lumborum block (QLB) when used in conjunction with continuous lumbar plexus block (LPB) for postoperative analgesia in children and adolescents undergoing unilateral hip surgical procedures. The aim of this study is to compare the efficacy of the QL vs. ESP blocks as supplements to the lumbar plexus block with respect to pain control outcomes after hip PAO surgery. Both blocks are safe and easy to perform. There is currently no comparative, prospective data concerning the use of these two blocks for hip surgery. The investigational hypothesis is that there will be no clinical difference in the amount of opioid consumed or the overall pain control offered by these two block options.
Read the detailed description
The Bernese periacetabular osteotomy (PAO) is currently performed at this institution as a non-arthroplasty option to treat developmental hip dysplasia in symptomatic adolescents and young adults. Extensive orthopedic surgical procedures of the hip such as this are associated with severe postoperative pain and benefit from regional anesthesia which provides dense, targeted analgesia to selected dermatomes. These blocks have the potential to decrease opioid exposure intraoperatively and postoperatively, thus avoiding opioid-related side effects such as nausea and vomiting. Other well-known benefits of regional anesthesia in other surgeries include earlier extubation, shorter ICU admissions, shortened post anesthesia care unit (PACU) stays, earlier mobilization, facilitation of physical therapy, improving patient satisfaction, and improved comfort during recovery process. The opioid sparing advantages of regional anesthesia are particularly relevant given the current concerns over the opioid epidemic and data relating opioid administration around surgery recovery and long-term opioid use.
Innervation of the hip is very complex with contributions from various neural structures arising from the lumbar plexus, including branches of the femoral nerve (L2-L4) innervating the anterolateral capsule and obturator nerve (L2-L4) innervating the anteromedial capsule. The posterior and inferior part of the hip joint are innervated by the sacral plexus consisting of the superior gluteal nerve (L4-S1) and branches of the sciatic (L4-S3) including the nerve to rectus femoris (L4-S1).
The skin areas involved in the two most common hip PAO surgery incisions (ilioinguinal incision or the iliofemoral incision) include territories that are innervated by subcostal nerve (T12) and ilioinguinal and iliohypogastric nerves (L1), 4 neural structures not reliably covered with the lumbar plexus block given their origin far more superior from the point of injection which is usually between L2 and L4. For this reason, supplemental blocks such as the ESB and QLB have been employed to improve nerve block coverage and pain control. The lateral femoral cutaneous nerve (L1) which is a sensory branch of the lumbar plexus that supplies skin of the lateral thigh, has a less important role in this context given that the surgical incisions are far more anterior to its territory of innervation.
Surgical osteotomies commonly associated with the Bernese procedure are performed on the anterior portion of the ischium, superior pubic ramus, posterior; partial osteotomies of the ischium below the acetabulum are common as well. Arthrotomy is only performed in selected cases if there is concern for intraarticular pathology, such as a torn labrum, lesions of the femoral neck, or loose bodies. The pelvic bone with its respective osteotome (i.e. bone) innervation includes territories ranging from L2 to S1.7 Some evidence suggest that the iliac crest receives its main sensory innervation from femoral nerve while the gluteal surface of the ilium comes from the sciatic nerve.
Given the many dermatomes and osteotomes that are involved, various regional anesthetic techniques have been described, including LPB, fascia iliaca block, femoral nerve block, obturator nerve block, sacral plexus block, paravertebral blocks, and also interfascial plane blocks like QLB and ESB.
The lumbar plexus block has been shown to provide prolonged analgesia and reduced analgesic requirements in postoperative period for pediatric patients undergoing hip surgery. This block targets mainly femoral, obturator, and lateral femoral cutaneous nerves. At this institution, ultrasound-guided lumbar plexus block using the "shamrock method" has been performed as standard of care for PAO surgery.
Skin incisions include dermatomes T12 to L1 that are not usually covered by the lumbar plexus block. For full coverage, it is necessary to add a supplementary block to cover these dermatomes. The options for this coverage are the QLB, the ESB, or paravertebral block (PVB). Due to the lack of evidence of superiority for any one of these additional blocks over another, the choice of the block is most often made based on the preference of the regional anesthesia team. All three blocks have been reported as effectively covering the cutaneous incision areas. A retrospective preliminary analysis of local data comparing these supplementary blocks suggested a potential difference favoring ESB in terms of opioid consumption when compared to PV or QL.
The QLB blocks the anterior branches of thoracoabdominal nerves and may extend to the upper branches of the lumbar plexus and lateral cutaneous branches of the thoracoabdominal nerves with possible spread to the paravertebral space. There are at least four different variants described in literature based on the site of injection in relation to the quadratus lumborum muscle: type 1 (lateral), type 2 (posterior), type 3 (anterior or transmuscular) and type 4 (intramuscular) - each causing different spread patterns of injectate with affected dermatomes ranging from thoracic T6 to lumbar L2. There is no literature evidence suggesting that one specific QLB approach is superior than the others in terms of clinical outcomes or duration in this setting.
The ESB is a novel block developed in 2016. A rapidly growing body of literature suggests it is efficacious in relieving back, chest wall, abdominal wall and flank pain in both acute and chronic settings. It has been shown to be a viable option for breast, spine, thoracic and abdominal surgical procedures. Recently it has also been reported as an alternative for hip surgery analgesia. Depending on the level of application, this block permits an extensive craniocaudal spread of the local anesthetic along the fascial plane underlying erector spinae muscle allowing multiple dermatomal coverage from a single injection. At lumbar level it can spread from the T12 to S1 vertebrae.
The aim of our study is to compare the efficacy of the QL vs. ESB blocks as supplements to the lumbar plexus block with respect to pain control outcomes after hip PAO surgery. Both blocks are safe and easy to perform. There is currently no comparative, prospective data concerning the use of these two blocks for hip surgery. The investigational hypothesis is that there will be no clinical difference in the amount of opioid consumed or the overall pain control offered by these two block options.
The investigators propose a randomized, controlled, non-inferiority trial to compare the effectiveness of QLBs versus ESBs as supplementary blocks to continuous LPB for patients undergoing primary periacetabular osteotomies. They will compare rescue analgesic requirements, rendered as opiate equivalents, at 24, 48 and 72 hours postoperatively as the primary endpoint. Patients aged 15 years - 30 years of age will be recruited from the home insitution.
- Conditions
- Pain, Postoperative, Regional Anesthesia, Hip Dysplasia
- Being tested
- Erector spinae block with ropivacaine 0.2%, Quadratus lumborum block with ropivacaine 0.2%, Ropivacaine
- Keywords
- pain, regional anesthesia, regional block, lumbar plexus block, erector spinae block, paravertebral block, continuous nerve block, postoperative pain
- Medical subject headings
- Pain, Postoperative, Hip Dislocation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae block with ropivacaine 0.2%Procedure or surgery
Also called regional nerve block, ropivacaine
Single-shot ultrasound-guided nerve block performed ipsilateral to surgical site.
Quadratus lumborum block with ropivacaine 0.2%Procedure or surgery
Also called regional nerve block, ropivacaine
Single-shot ultrasound-guided nerve block performed ipsilateral to surgical site.
RopivacaineDrug
Also called Naropin
ropivacaine 0.2% nerve block injection
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae supplemental block | Experimental | Single-shot T9/T10 operative side erector spinae block using ropivacaine 0.2%, 0.5ml/kg. Receives: Procedure: Erector spinae block with ropivacaine 0.2%; Drug: Ropivacaine |
| Quadratus lumborum supplemental block | Active comparator | Single-shot T9/T10 operative side quadratus lumborum (type 1) block using ropivacaine 0.2%, 0.5ml/kg. Receives: Procedure: Quadratus lumborum block with ropivacaine 0.2%; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rescue analgesic consumption
Opioid use via PCA
Measured: Day 1
Secondary outcomes (3)
Mean pain scores
Numerical rating scale for pain (0-10, with 10 indicating most pain)
Measured: Every 12 hours
PACU Time
Total time spent in PACU
Measured: PACU stay
Adverse events
Any unexpected outcome attributable to intervention
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start1 Dec 2020
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Why it stopped: Lack of interest.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arm randomized controlled non-inferiority trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roland Brusseau, Boston Children's Hospital
- Investigators
- ROLAND BRUSSEAU, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481451
- Sponsor's protocol ID
- IRB-P00034474
- Status last verified
- Dec 2025
- First submitted
- 15 Jul 2020
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum vs Erector Spinae Supplementary Blocks With Lumbar Plexus Blocks for Hip PAO
- ClinicalTrials.gov ID
- NCT04481451
- Acronym / sponsor ID
- IRB-P00034474
- Conditions
- Pain, Postoperative, Regional Anesthesia, Hip Dysplasia
- Keywords
- pain, regional anesthesia, regional block, lumbar plexus block, erector spinae block, paravertebral block, continuous nerve block, postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of interest.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 22 Jul 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.
This study proposes to evaluate the efficacy of single shot erector spinae block (ESB) versus single shot quadratus lumborum block (QLB) when used in conjunction with continuous lumbar plexus block (LPB) for postoperative analgesia in children and adolescents undergoing unilateral hip surgical procedures. The aim of this study is to compare the efficacy of the QL vs. ESP blocks as supplements to the lumbar plexus block with respect to pain control outcomes after hip PAO surgery. Both blocks are safe and easy to perform. There is currently no comparative, prospective data concerning the use of these two blocks for hip surgery. The investigational hypothesis is that there will be no clinical difference in the amount of opioid consumed or the overall pain control offered by these two block options.
Detailed description
The Bernese periacetabular osteotomy (PAO) is currently performed at this institution as a non-arthroplasty option to treat developmental hip dysplasia in symptomatic adolescents and young adults. Extensive orthopedic surgical procedures of the hip such as this are associated with severe postoperative pain and benefit from regional anesthesia which provides dense, targeted analgesia to selected dermatomes. These blocks have the potential to decrease opioid exposure intraoperatively and postoperatively, thus avoiding opioid-related side effects such as nausea and vomiting. Other well-known benefits of regional anesthesia in other surgeries include earlier extubation, shorter ICU admissions, shortened post anesthesia care unit (PACU) stays, earlier mobilization, facilitation of physical therapy, improving patient satisfaction, and improved comfort during recovery process. The opioid sparing advantages of regional anesthesia are particularly relevant given the current concerns over the opioid epidemic and data relating opioid administration around surgery recovery and long-term opioid use.
Innervation of the hip is very complex with contributions from various neural structures arising from the lumbar plexus, including branches of the femoral nerve (L2-L4) innervating the anterolateral capsule and obturator nerve (L2-L4) innervating the anteromedial capsule. The posterior and inferior part of the hip joint are innervated by the sacral plexus consisting of the superior gluteal nerve (L4-S1) and branches of the sciatic (L4-S3) including the nerve to rectus femoris (L4-S1).
The skin areas involved in the two most common hip PAO surgery incisions (ilioinguinal incision or the iliofemoral incision) include territories that are innervated by subcostal nerve (T12) and ilioinguinal and iliohypogastric nerves (L1), 4 neural structures not reliably covered with the lumbar plexus block given their origin far more superior from the point of injection which is usually between L2 and L4. For this reason, supplemental blocks such as the ESB and QLB have been employed to improve nerve block coverage and pain control. The lateral femoral cutaneous nerve (L1) which is a sensory branch of the lumbar plexus that supplies skin of the lateral thigh, has a less important role in this context given that the surgical incisions are far more anterior to its territory of innervation.
Surgical osteotomies commonly associated with the Bernese procedure are performed on the anterior portion of the ischium, superior pubic ramus, posterior; partial osteotomies of the ischium below the acetabulum are common as well. Arthrotomy is only performed in selected cases if there is concern for intraarticular pathology, such as a torn labrum, lesions of the femoral neck, or loose bodies. The pelvic bone with its respective osteotome (i.e. bone) innervation includes territories ranging from L2 to S1.7 Some evidence suggest that the iliac crest receives its main sensory innervation from femoral nerve while the gluteal surface of the ilium comes from the sciatic nerve.
Given the many dermatomes and osteotomes that are involved, various regional anesthetic techniques have been described, including LPB, fascia iliaca block, femoral nerve block, obturator nerve block, sacral plexus block, paravertebral blocks, and also interfascial plane blocks like QLB and ESB.
The lumbar plexus block has been shown to provide prolonged analgesia and reduced analgesic requirements in postoperative period for pediatric patients undergoing hip surgery. This block targets mainly femoral, obturator, and lateral femoral cutaneous nerves. At this institution, ultrasound-guided lumbar plexus block using the "shamrock method" has been performed as standard of care for PAO surgery.
Skin incisions include dermatomes T12 to L1 that are not usually covered by the lumbar plexus block. For full coverage, it is necessary to add a supplementary block to cover these dermatomes. The options for this coverage are the QLB, the ESB, or paravertebral block (PVB). Due to the lack of evidence of superiority for any one of these additional blocks over another, the choice of the block is most often made based on the preference of the regional anesthesia team. All three blocks have been reported as effectively covering the cutaneous incision areas. A retrospective preliminary analysis of local data comparing these supplementary blocks suggested a potential difference favoring ESB in terms of opioid consumption when compared to PV or QL.
The QLB blocks the anterior branches of thoracoabdominal nerves and may extend to the upper branches of the lumbar plexus and lateral cutaneous branches of the thoracoabdominal nerves with possible spread to the paravertebral space. There are at least four different variants described in literature based on the site of injection in relation to the quadratus lumborum muscle: type 1 (lateral), type 2 (posterior), type 3 (anterior or transmuscular) and type 4 (intramuscular) - each causing different spread patterns of injectate with affected dermatomes ranging from thoracic T6 to lumbar L2. There is no literature evidence suggesting that one specific QLB approach is superior than the others in terms of clinical outcomes or duration in this setting.
The ESB is a novel block developed in 2016. A rapidly growing body of literature suggests it is efficacious in relieving back, chest wall, abdominal wall and flank pain in both acute and chronic settings. It has been shown to be a viable option for breast, spine, thoracic and abdominal surgical procedures. Recently it has also been reported as an alternative for hip surgery analgesia. Depending on the level of application, this block permits an extensive craniocaudal spread of the local anesthetic along the fascial plane underlying erector spinae muscle allowing multiple dermatomal coverage from a single injection. At lumbar level it can spread from the T12 to S1 vertebrae.
The aim of our study is to compare the efficacy of the QL vs. ESB blocks as supplements to the lumbar plexus block with respect to pain control outcomes after hip PAO surgery. Both blocks are safe and easy to perform. There is currently no comparative, prospective data concerning the use of these two blocks for hip surgery. The investigational hypothesis is that there will be no clinical difference in the amount of opioid consumed or the overall pain control offered by these two block options.
The investigators propose a randomized, controlled, non-inferiority trial to compare the effectiveness of QLBs versus ESBs as supplementary blocks to continuous LPB for patients undergoing primary periacetabular osteotomies. They will compare rescue analgesic requirements, rendered as opiate equivalents, at 24, 48 and 72 hours postoperatively as the primary endpoint. Patients aged 15 years - 30 years of age will be recruited from the home insitution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 arm randomized controlled non-inferiority trial.
| Arm | Type | Receives |
|---|---|---|
| Erector spinae supplemental block | Experimental | Procedure: Erector spinae block with ropivacaine 0.2%, Drug: RopivacaineSingle-shot T9/T10 operative side erector spinae block using ropivacaine 0.2%, 0.5ml/kg. |
| Quadratus lumborum supplemental block | Active comparator | Procedure: Quadratus lumborum block with ropivacaine 0.2%, Drug: RopivacaineSingle-shot T9/T10 operative side quadratus lumborum (type 1) block using ropivacaine 0.2%, 0.5ml/kg. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- ASA I - III status, undergoing unilateral periacetabular osteotomy for treating primary diagnosis of developmental acetabular dysplasia in symptomatic young patients.
- Ages 15 - 30 years
Key exclusion criteria (8 listed)
- Patients undergoing procedures including revision PAO, bilateral PAO, conversion to total hip arthroplasty.
- Patients whom for any reason did not received a lumbar plexus catheter as part of the baseline regional anesthesia plan
- Patients with body mass index (BMI) > 35
- Patients with known coagulopathies.
- Patients with severe neurodevelopmental delays.
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 |
|---|---|---|
| Erector spinae block with ropivacaine 0.2%Also: regional nerve block, ropivacaineSingle-shot ultrasound-guided nerve block performed ipsilateral to surgical site. | Procedure or surgery | Erector spinae supplemental block |
| Quadratus lumborum block with ropivacaine 0.2%Also: regional nerve block, ropivacaineSingle-shot ultrasound-guided nerve block performed ipsilateral to surgical site. | Procedure or surgery | Quadratus lumborum supplemental block |
| RopivacaineAlso: Naropinropivacaine 0.2% nerve block injection | Drug | Erector spinae supplemental block, Quadratus lumborum supplemental block |
Primary outcome
Rescue analgesic consumption
Time frame: Day 1
Opioid use via PCA
3 secondary outcomes
Mean pain scores
Time frame: Every 12 hours
PACU Time
Time frame: PACU stay
Adverse events
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- 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.
ROLAND BRUSSEAU, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erector spinae block with ropivacaine 0.2%, Quadratus lumborum block with ropivacaine 0.2% and Ropivacaine in people with Pain, Postoperative and Regional Anesthesia, run by Boston Children's Hospital at 1 site in United States.
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 2 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: withdrawn, as of the sponsor's last update on 12 Dec 2025. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rescue analgesic consumption (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2025.