<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04481451</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00034474</org_study_id>
    <nct_id>NCT04481451</nct_id>
  </id_info>
  <brief_title>Quadratus Lumborum vs Erector Spinae Supplementary Blocks With Lumbar Plexus Blocks for Hip PAO</brief_title>
  <official_title>Quadratus Lumborum vs Erector Spinae Supplementary Blocks With Lumbar Plexus Blocks for Hip PAO</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study proposes to evaluate the efficacy of single shot erector spinae block (ESB) versus&#xD;
      single shot quadratus lumborum block (QLB) when used in conjunction with continuous lumbar&#xD;
      plexus block (LPB) for postoperative analgesia in children and adolescents undergoing&#xD;
      unilateral hip surgical procedures. The aim of this study is to compare the efficacy of the&#xD;
      QL vs. ESP blocks as supplements to the lumbar plexus block with respect to pain control&#xD;
      outcomes after hip PAO surgery. Both blocks are safe and easy to perform. There is currently&#xD;
      no comparative, prospective data concerning the use of these two blocks for hip surgery. The&#xD;
      investigational hypothesis is that there will be no clinical difference in the amount of&#xD;
      opioid consumed or the overall pain control offered by these two block options.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Bernese periacetabular osteotomy (PAO) is currently performed at this institution as a&#xD;
      non-arthroplasty option to treat developmental hip dysplasia in symptomatic adolescents and&#xD;
      young adults. Extensive orthopedic surgical procedures of the hip such as this are associated&#xD;
      with severe postoperative pain and benefit from regional anesthesia which provides dense,&#xD;
      targeted analgesia to selected dermatomes. These blocks have the potential to decrease opioid&#xD;
      exposure intraoperatively and postoperatively, thus avoiding opioid-related side effects such&#xD;
      as nausea and vomiting. Other well-known benefits of regional anesthesia in other surgeries&#xD;
      include earlier extubation, shorter ICU admissions, shortened post anesthesia care unit&#xD;
      (PACU) stays, earlier mobilization, facilitation of physical therapy, improving patient&#xD;
      satisfaction, and improved comfort during recovery process. The opioid sparing advantages of&#xD;
      regional anesthesia are particularly relevant given the current concerns over the opioid&#xD;
      epidemic and data relating opioid administration around surgery recovery and long-term opioid&#xD;
      use.&#xD;
&#xD;
      Innervation of the hip is very complex with contributions from various neural structures&#xD;
      arising from the lumbar plexus, including branches of the femoral nerve (L2-L4) innervating&#xD;
      the anterolateral capsule and obturator nerve (L2-L4) innervating the anteromedial capsule.&#xD;
      The posterior and inferior part of the hip joint are innervated by the sacral plexus&#xD;
      consisting of the superior gluteal nerve (L4-S1) and branches of the sciatic (L4-S3)&#xD;
      including the nerve to rectus femoris (L4-S1).&#xD;
&#xD;
      The skin areas involved in the two most common hip PAO surgery incisions (ilioinguinal&#xD;
      incision or the iliofemoral incision) include territories that are innervated by subcostal&#xD;
      nerve (T12) and ilioinguinal and iliohypogastric nerves (L1), 4 neural structures not&#xD;
      reliably covered with the lumbar plexus block given their origin far more superior from the&#xD;
      point of injection which is usually between L2 and L4. For this reason, supplemental blocks&#xD;
      such as the ESB and QLB have been employed to improve nerve block coverage and pain control.&#xD;
      The lateral femoral cutaneous nerve (L1) which is a sensory branch of the lumbar plexus that&#xD;
      supplies skin of the lateral thigh, has a less important role in this context given that the&#xD;
      surgical incisions are far more anterior to its territory of innervation.&#xD;
&#xD;
      Surgical osteotomies commonly associated with the Bernese procedure are performed on the&#xD;
      anterior portion of the ischium, superior pubic ramus, posterior; partial osteotomies of the&#xD;
      ischium below the acetabulum are common as well. Arthrotomy is only performed in selected&#xD;
      cases if there is concern for intraarticular pathology, such as a torn labrum, lesions of the&#xD;
      femoral neck, or loose bodies. The pelvic bone with its respective osteotome (i.e. bone)&#xD;
      innervation includes territories ranging from L2 to S1.7 Some evidence suggest that the iliac&#xD;
      crest receives its main sensory innervation from femoral nerve while the gluteal surface of&#xD;
      the ilium comes from the sciatic nerve.&#xD;
&#xD;
      Given the many dermatomes and osteotomes that are involved, various regional anesthetic&#xD;
      techniques have been described, including LPB, fascia iliaca block, femoral nerve block,&#xD;
      obturator nerve block, sacral plexus block, paravertebral blocks, and also interfascial plane&#xD;
      blocks like QLB and ESB.&#xD;
&#xD;
      The lumbar plexus block has been shown to provide prolonged analgesia and reduced analgesic&#xD;
      requirements in postoperative period for pediatric patients undergoing hip surgery. This&#xD;
      block targets mainly femoral, obturator, and lateral femoral cutaneous nerves. At this&#xD;
      institution, ultrasound-guided lumbar plexus block using the &quot;shamrock method&quot; has been&#xD;
      performed as standard of care for PAO surgery.&#xD;
&#xD;
      Skin incisions include dermatomes T12 to L1 that are not usually covered by the lumbar plexus&#xD;
      block. For full coverage, it is necessary to add a supplementary block to cover these&#xD;
      dermatomes. The options for this coverage are the QLB, the ESB, or paravertebral block (PVB).&#xD;
      Due to the lack of evidence of superiority for any one of these additional blocks over&#xD;
      another, the choice of the block is most often made based on the preference of the regional&#xD;
      anesthesia team. All three blocks have been reported as effectively covering the cutaneous&#xD;
      incision areas. A retrospective preliminary analysis of local data comparing these&#xD;
      supplementary blocks suggested a potential difference favoring ESB in terms of opioid&#xD;
      consumption when compared to PV or QL.&#xD;
&#xD;
      The QLB blocks the anterior branches of thoracoabdominal nerves and may extend to the upper&#xD;
      branches of the lumbar plexus and lateral cutaneous branches of the thoracoabdominal nerves&#xD;
      with possible spread to the paravertebral space. There are at least four different variants&#xD;
      described in literature based on the site of injection in relation to the quadratus lumborum&#xD;
      muscle: type 1 (lateral), type 2 (posterior), type 3 (anterior or transmuscular) and type 4&#xD;
      (intramuscular) - each causing different spread patterns of injectate with affected&#xD;
      dermatomes ranging from thoracic T6 to lumbar L2. There is no literature evidence suggesting&#xD;
      that one specific QLB approach is superior than the others in terms of clinical outcomes or&#xD;
      duration in this setting.&#xD;
&#xD;
      The ESB is a novel block developed in 2016. A rapidly growing body of literature suggests it&#xD;
      is efficacious in relieving back, chest wall, abdominal wall and flank pain in both acute and&#xD;
      chronic settings. It has been shown to be a viable option for breast, spine, thoracic and&#xD;
      abdominal surgical procedures. Recently it has also been reported as an alternative for hip&#xD;
      surgery analgesia. Depending on the level of application, this block permits an extensive&#xD;
      craniocaudal spread of the local anesthetic along the fascial plane underlying erector spinae&#xD;
      muscle allowing multiple dermatomal coverage from a single injection. At lumbar level it can&#xD;
      spread from the T12 to S1 vertebrae.&#xD;
&#xD;
      The aim of our study is to compare the efficacy of the QL vs. ESB blocks as supplements to&#xD;
      the lumbar plexus block with respect to pain control outcomes after hip PAO surgery. Both&#xD;
      blocks are safe and easy to perform. There is currently no comparative, prospective data&#xD;
      concerning the use of these two blocks for hip surgery. The investigational hypothesis is&#xD;
      that there will be no clinical difference in the amount of opioid consumed or the overall&#xD;
      pain control offered by these two block options.&#xD;
&#xD;
      The investigators propose a randomized, controlled, non-inferiority trial to compare the&#xD;
      effectiveness of QLBs versus ESBs as supplementary blocks to continuous LPB for patients&#xD;
      undergoing primary periacetabular osteotomies. They will compare rescue analgesic&#xD;
      requirements, rendered as opiate equivalents, at 24, 48 and 72 hours postoperatively as the&#xD;
      primary endpoint. Patients aged 15 years - 30 years of age will be recruited from the home&#xD;
      insitution.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>2 arm randomized controlled non-inferiority trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>The identity of the study block type will be hidden from caregivers unless clinically mandated.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Rescue analgesic consumption</measure>
    <time_frame>Day 1</time_frame>
    <description>Opioid use via PCA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean pain scores</measure>
    <time_frame>Every 12 hours</time_frame>
    <description>Numerical rating scale for pain (0-10, with 10 indicating most pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PACU Time</measure>
    <time_frame>PACU stay</time_frame>
    <description>Total time spent in PACU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>2 weeks</time_frame>
    <description>Any unexpected outcome attributable to intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">156</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Regional Anesthesia</condition>
  <condition>Hip Dysplasia</condition>
  <arm_group>
    <arm_group_label>Erector spinae supplemental block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single-shot T9/T10 operative side erector spinae block using ropivacaine 0.2%, 0.5ml/kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quadratus lumborum supplemental block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single-shot T9/T10 operative side quadratus lumborum (type 1) block using ropivacaine 0.2%, 0.5ml/kg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Erector spinae block with ropivacaine 0.2%</intervention_name>
    <description>Single-shot ultrasound-guided nerve block performed ipsilateral to surgical site.</description>
    <arm_group_label>Erector spinae supplemental block</arm_group_label>
    <other_name>regional nerve block</other_name>
    <other_name>ropivacaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Quadratus lumborum block with ropivacaine 0.2%</intervention_name>
    <description>Single-shot ultrasound-guided nerve block performed ipsilateral to surgical site.</description>
    <arm_group_label>Quadratus lumborum supplemental block</arm_group_label>
    <other_name>regional nerve block</other_name>
    <other_name>ropivacaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>ropivacaine 0.2% nerve block injection</description>
    <arm_group_label>Erector spinae supplemental block</arm_group_label>
    <arm_group_label>Quadratus lumborum supplemental block</arm_group_label>
    <other_name>Naropin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ASA I - III status, undergoing unilateral periacetabular osteotomy for treating&#xD;
             primary diagnosis of developmental acetabular dysplasia in symptomatic young patients.&#xD;
&#xD;
          2. Ages 15 - 30 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients undergoing procedures including revision PAO, bilateral PAO, conversion to&#xD;
             total hip arthroplasty.&#xD;
&#xD;
          2. Patients whom for any reason did not received a lumbar plexus catheter as part of the&#xD;
             baseline regional anesthesia plan&#xD;
&#xD;
          3. Patients with body mass index (BMI) &gt; 35&#xD;
&#xD;
          4. Patients with known coagulopathies.&#xD;
&#xD;
          5. Patients with severe neurodevelopmental delays.&#xD;
&#xD;
          6. Patients with previous chronic pain syndromes.&#xD;
&#xD;
          7. Patients with a history of opioid treatment at any point in the 2 months prior to&#xD;
             surgery.&#xD;
&#xD;
          8. Lack of parental consent and/or patient assent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ROLAND BRUSSEAU, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ROLAND BRUSSEAU, MD</last_name>
    <phone>6173557737</phone>
    <email>roland.brusseau@childrens.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Boston Children&quot;S Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ROLAND BRUSSEAU, MD</last_name>
      <phone>617-355-7737</phone>
      <email>roland.brusseau@childrens.harvard.du</email>
    </contact>
    <contact_backup>
      <last_name>MD</last_name>
    </contact_backup>
    <investigator>
      <last_name>Jocelyn Booth, RN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>BERNIER RACHEL, BS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ivy Pham, BS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>September 8, 2022</last_update_submitted>
  <last_update_submitted_qc>September 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Roland Brusseau</investigator_full_name>
    <investigator_title>Director, Pediatric Regional Anesthesia Services</investigator_title>
  </responsible_party>
  <keyword>pain</keyword>
  <keyword>regional anesthesia</keyword>
  <keyword>regional block</keyword>
  <keyword>lumbar plexus block</keyword>
  <keyword>erector spinae block</keyword>
  <keyword>paravertebral block</keyword>
  <keyword>continuous nerve block</keyword>
  <keyword>postoperative pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hip Dislocation</mesh_term>
    <mesh_term>Developmental Dysplasia of the Hip</mesh_term>
    <mesh_term>Hip Dislocation, Congenital</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04481451
org study id: IRB-P00034474
nct id: NCT04481451
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 2 arm randomized controlled non-inferiority trial.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: The identity of the study block type will be hidden from caregivers unless clinically mandated.
measure: Rescue analgesic consumption
time frame: Day 1
description: Opioid use via PCA
measure: Mean pain scores
time frame: Every 12 hours
description: Numerical rating scale for pain (0-10, with 10 indicating most pain)
measure: PACU Time
time frame: PACU stay
description: Total time spent in PACU
measure: Adverse events
time frame: 2 weeks
description: Any unexpected outcome attributable to intervention
arm group label: Erector spinae supplemental block
arm group type: Experimental
description: Single-shot T9/T10 operative side erector spinae block using ropivacaine 0.2%, 0.5ml/kg.
arm group label: Quadratus lumborum supplemental block
arm group type: Active Comparator
description: Single-shot T9/T10 operative side quadratus lumborum (type 1) block using ropivacaine 0.2%, 0.5ml/kg.
intervention type: Procedure
intervention name: Erector spinae block with ropivacaine 0.2%
description: Single-shot ultrasound-guided nerve block performed ipsilateral to surgical site.
arm group label: Erector spinae supplemental block
other name: regional nerve block
other name: ropivacaine
intervention type: Procedure
intervention name: Quadratus lumborum block with ropivacaine 0.2%
description: Single-shot ultrasound-guided nerve block performed ipsilateral to surgical site.
arm group label: Quadratus lumborum supplemental block
other name: regional nerve block
other name: ropivacaine
intervention type: Drug
intervention name: Ropivacaine
description: ropivacaine 0.2% nerve block injection
arm group label: Erector spinae supplemental block
arm group label: Quadratus lumborum supplemental block
other name: Naropin
criteria: 
gender: All
minimum age: 15 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: ROLAND BRUSSEAU, MD
role: Principal Investigator
affiliation: Boston Children's Hospital
last name: ROLAND BRUSSEAU, MD
phone: 6173557737
email: roland.brusseau@childrens.harvard.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Roland Brusseau
investigator title: Director, Pediatric Regional Anesthesia Services
mesh term: Hip Dislocation
mesh term: Developmental Dysplasia of the Hip
mesh term: Hip Dislocation, Congenital
mesh term: Pain, Postoperative
mesh term: Ropivacaine
sharing ipd: No