Clinical trial

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

Name
IRB-P00034474
Description
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.
Trial arms
Trial start
2020-12-01
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Erector spinae block with ropivacaine 0.2%
Single-shot ultrasound-guided nerve block performed ipsilateral to surgical site.
Arms:
Erector spinae supplemental block
Other names:
regional nerve block, ropivacaine
Quadratus lumborum block with ropivacaine 0.2%
Single-shot ultrasound-guided nerve block performed ipsilateral to surgical site.
Arms:
Quadratus lumborum supplemental block
Other names:
regional nerve block, ropivacaine
Ropivacaine
ropivacaine 0.2% nerve block injection
Arms:
Erector spinae supplemental block, Quadratus lumborum supplemental block
Other names:
Naropin
Size
156
Primary endpoint
Rescue analgesic consumption
Day 1
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 arm randomized controlled non-inferiority trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'The identity of the study block type will be hidden from caregivers unless clinically mandated.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 156, 'type': 'ESTIMATED'}}
Updated at
2024-01-31

1 organization

1 product

4 indications

Indication
Pain
Indication
Postoperative
Indication
Hip Dysplasia