ClinicalTrials.gg
WithdrawnNCT04481451Updated Dec 12, 2025

Quadratus Lumborum vs Erector Spinae Supplementary Blocks With Lumbar Plexus Blocks for Hip PAO

A Phase 4 interventional study of Erector spinae block with ropivacaine 0.2% and Quadratus lumborum block with ropivacaine 0.2% in Pain, Postoperative, Regional Anesthesia and Hip Dysplasia, sponsored by Boston Children's Hospital. Withdrawn at 1 site in United States. Open to participants aged 15 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-12.

Sponsored by Boston Children's Hospital · Phase 4, Interventional, and Treatment

Why this study was withdrawn
Lack of interest.
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
15 Years to 30 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • 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
03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

Browse Pain, Postoperative studies →

Lead sponsor

Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. status, undergoing unilateral periacetabular osteotomy for treating primary diagnosis of developmental acetabular dysplasia in symptomatic young patients.
  2. Ages 15 - 30 years

Exclusion criteria

Exclusion Criteria:

  1. Patients undergoing procedures including revision PAO, bilateral PAO, conversion to total hip arthroplasty.
  2. Patients whom for any reason did not received a lumbar plexus catheter as part of the baseline regional anesthesia plan
  3. Patients with (BMI) > 35
  4. Patients with known coagulopathies.
  5. Patients with severe neurodevelopmental delays.
  6. Patients with previous chronic pain syndromes.
  7. Patients with a history of opioid treatment at any point in the 2 months prior to surgery.
  8. Lack of parental consent and/or patient assent.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Erector spinae supplemental block

    Single-shot T9/T10 operative side erector spinae block using ropivacaine 0.2%, 0.5ml/kg.

    Procedure: Erector spinae block with ropivacaine 0.2% · Drug: Ropivacaine

  • Active comparator
    Quadratus lumborum supplemental block

    Single-shot T9/T10 operative side quadratus lumborum (type 1) block using ropivacaine 0.2%, 0.5ml/kg.

    Procedure: Quadratus lumborum block with ropivacaine 0.2% · Drug: Ropivacaine

Interventions

  • ProcedureErector spinae block with ropivacaine 0.2%

    Single-shot ultrasound-guided nerve block performed ipsilateral to surgical site.

    Also known as: regional nerve block, ropivacaine

  • ProcedureQuadratus lumborum block with ropivacaine 0.2%

    Single-shot ultrasound-guided nerve block performed ipsilateral to surgical site.

    Also known as: regional nerve block, ropivacaine

  • ropivacaine 0.2% nerve block injection

    Also known as: Naropin

06

What researchers measure

Primary outcomes

  1. Rescue analgesic consumption

    Opioid use via PCA

    Time frame: Day 1

Secondary outcomes

  1. Mean pain scores

    Numerical rating scale for pain (0-10, with 10 indicating most pain)

    Time frame: Every 12 hours

  2. PACU Time

    Total time spent in PACU

    Time frame: PACU stay

  3. Adverse events

    Any unexpected outcome attributable to intervention

    Time frame: 2 weeks

07

Study locations

1 site
  • Boston Children"S Hospital
    Boston, Massachusetts 02118, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04481451
Responsible party
Roland Brusseau (Director, Pediatric Regional Anesthesia Services, Boston Children's Hospital) — Principal investigator
First posted
Jul 22, 2020
Start date
Dec 1, 2020
Primary completion
Dec 1, 2025
Completion
Dec 1, 2025
Last update
Dec 12, 2025

Study contacts

ROLAND BRUSSEAU, MD
principal investigator · Boston Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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