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

NCT04481451 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: IRB-P00034474
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Rescue analgesic consumption

  Opioid use via PCA

  Day 1

Secondary Outcomes (3)

• Mean pain scores

  Every 12 hours

• PACU Time

  PACU stay

• Adverse events

  2 weeks

Study Arms (2)

Erector spinae supplemental block

EXPERIMENTAL

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

Quadratus lumborum supplemental block

ACTIVE COMPARATOR

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

Erector spinae block with ropivacaine 0.2% PROCEDURE

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

Also known as: regional nerve block, ropivacaine

Erector spinae supplemental block

Quadratus lumborum block with ropivacaine 0.2% PROCEDURE

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

Also known as: regional nerve block, ropivacaine

Quadratus lumborum supplemental block

Ropivacaine DRUG

ropivacaine 0.2% nerve block injection

Also known as: Naropin

Erector spinae supplemental block; Quadratus lumborum supplemental block

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children"S Hospital

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Hip Dislocation; Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• ROLAND BRUSSEAU, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The identity of the study block type will be hidden from caregivers unless clinically mandated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pediatric Regional Anesthesia Services

Model Details: 2 arm randomized controlled non-inferiority trial.

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 22, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)