跳至主要内容
临床试验/NCT04481451
NCT04481451撤回4 期

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

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2020年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
入组人数
156
试验地点
1
主要终点
Rescue analgesic consumption

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

The identity of the study block type will be hidden from caregivers unless clinically mandated.

入排标准

年龄范围
15 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Erector spinae supplemental block

Experimental

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

干预措施: Erector spinae block with ropivacaine 0.2% (Procedure)

Erector spinae supplemental block

Experimental

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

干预措施: Ropivacaine (Drug)

Quadratus lumborum supplemental block

Active Comparator

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

干预措施: Quadratus lumborum block with ropivacaine 0.2% (Procedure)

Quadratus lumborum supplemental block

Active Comparator

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

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Rescue analgesic consumption

时间窗: Day 1

Opioid use via PCA

次要结局

  • Mean pain scores(Every 12 hours)
  • PACU Time(PACU stay)
  • Adverse events(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Roland Brusseau

Director, Pediatric Regional Anesthesia Services

Boston Children's Hospital

研究点 (1)

Loading locations...

相似试验