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

Primary Purpose

Pain, Postoperative, Regional Anesthesia, Hip Dysplasia

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Erector spinae block with ropivacaine 0.2%
Quadratus lumborum block with ropivacaine 0.2%
Ropivacaine
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring pain, regional anesthesia, regional block, lumbar plexus block, erector spinae block, paravertebral block, continuous nerve block, postoperative pain

Eligibility Criteria

15 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

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 body mass index (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.

Sites / Locations

  • Boston Children"S HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Erector spinae supplemental block

Quadratus lumborum supplemental block

Arm Description

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

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

Outcomes

Primary Outcome Measures

Rescue analgesic consumption
Opioid use via PCA

Secondary Outcome Measures

Mean pain scores
Numerical rating scale for pain (0-10, with 10 indicating most pain)
PACU Time
Total time spent in PACU
Adverse events
Any unexpected outcome attributable to intervention

Full Information

First Posted
July 15, 2020
Last Updated
October 17, 2023
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04481451
Brief Title
Quadratus Lumborum vs Erector Spinae Supplementary Blocks With Lumbar Plexus Blocks for Hip PAO
Official Title
Quadratus Lumborum vs Erector Spinae Supplementary Blocks With Lumbar Plexus Blocks for Hip PAO
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
2 arm randomized controlled non-inferiority trial.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The identity of the study block type will be hidden from caregivers unless clinically mandated.
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Erector spinae supplemental block
Arm Type
Experimental
Arm Description
Single-shot T9/T10 operative side erector spinae block using ropivacaine 0.2%, 0.5ml/kg.
Arm Title
Quadratus lumborum supplemental block
Arm Type
Active Comparator
Arm Description
Single-shot T9/T10 operative side quadratus lumborum (type 1) block using ropivacaine 0.2%, 0.5ml/kg.
Intervention Type
Procedure
Intervention Name(s)
Erector spinae block with ropivacaine 0.2%
Other Intervention Name(s)
regional nerve block, ropivacaine
Intervention Description
Single-shot ultrasound-guided nerve block performed ipsilateral to surgical site.
Intervention Type
Procedure
Intervention Name(s)
Quadratus lumborum block with ropivacaine 0.2%
Other Intervention Name(s)
regional nerve block, ropivacaine
Intervention Description
Single-shot ultrasound-guided nerve block performed ipsilateral to surgical site.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
ropivacaine 0.2% nerve block injection
Primary Outcome Measure Information:
Title
Rescue analgesic consumption
Description
Opioid use via PCA
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Mean pain scores
Description
Numerical rating scale for pain (0-10, with 10 indicating most pain)
Time Frame
Every 12 hours
Title
PACU Time
Description
Total time spent in PACU
Time Frame
PACU stay
Title
Adverse events
Description
Any unexpected outcome attributable to intervention
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA I - III status, undergoing unilateral periacetabular osteotomy for treating primary diagnosis of developmental acetabular dysplasia in symptomatic young patients. Ages 15 - 30 years Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ROLAND BRUSSEAU, MD
Phone
6173557737
Email
roland.brusseau@childrens.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ROLAND BRUSSEAU, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children"S Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ROLAND BRUSSEAU, MD
Phone
617-355-7737
Email
roland.brusseau@childrens.harvard.du
First Name & Middle Initial & Last Name & Degree
MD
First Name & Middle Initial & Last Name & Degree
Jocelyn Booth, RN
First Name & Middle Initial & Last Name & Degree
BERNIER RACHEL, BS
First Name & Middle Initial & Last Name & Degree
Ivy Pham, BS

12. IPD Sharing Statement

Plan to Share IPD
No

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

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