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临床试验/NCT06420336
NCT06420336招募中不适用

Quadratus Lumborum Block for Pain Control in Unilateral Anterior Iliac Bone Graft Harvesting for Pediatric Patients Undergoing Palatoplasty: a Prospective Randomized Control Trial

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年6月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
46
试验地点
2
主要终点
Pain Scores

研究概览

简要总结

This study will consist of patients ages 6-18 who are undergoing a surgery on the hard or soft palate of the mouth (palatoplasty), with removal of bone from the front of the hip (anterior iliac bone graft harvesting). The patients will be randomized to receive either a unilateral QL block by an anesthesiologist, or local anesthetic infiltration at the surgical incision by the surgeon. The primary aim will be assessing post-operative pain in the first 48 hours after surgery. Secondary outcomes will include pain medication use in the first 48 hours after surgery, block resolution time, and evaluating any complications associated with the QL block or local anesthetic infiltration.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing palatoplasty with autologous bone graft from the anterior iliac crest.
  • Ages 6-18 years of age
  • Planned admission post-op
  • ASA Status Range: 1-3

排除标准

  • Contraindication to QL blocks or LAI which may include:
  • overlying infection skin at the block needle insertion site
  • coagulopathies
  • known bleeding disorders
  • Allergy to local anesthetic
  • Cognitive or developmental impairment that would limit ability to report pain.
  • Non-English Speaking/Writing
  • Subjects or their parent/guardian unable or choose to not give informed consent/assent.

研究组 & 干预措施

Quadratus lumborum block

Active Comparator

After induction of anesthesia and securement of appropriate airway device, the patient will be placed in position for the QL block. Using ultrasound guidance, the pediatric anesthesiology attending will perform unilateral QL block on the side of the anterior iliac bone graft harvest. The dose will be 0.2% ropivacaine, 1 mL per kilogram to a max of 20 mL with an additive of dexamethasone 4 mg. Ultrasonography will be used to identify external oblique, internal oblique, transverse abdominus and quadratus lumborum muscles. A 50 mm-150 mm block needle will be advanced under ultrasound guidance. Ropivacaine will be injected slowly with frequent aspiration to rule out incorrect needle placement. The anesthetic is deposited at the lateral edge of the QL after penetrating the transversus abdominus aponeurosis. Injection will continue to be observed with real time US guidance.

干预措施: Quadratus lumborum block (Procedure)

Local anesthetic infiltration

Active Comparator

Patient will undergo induction of anesthesia as deemed appropriate by the attending pediatric anesthesiologist assigned to the case. After induction of anesthesia and securement of appropriate airway device the patient will be turned over to the surgical team to proceed with the operation. The surgeon will proceed with usual injection of local anesthetic as their standard of care; this medication will be charted by the circulating nurse in the Medication Administration Record with local anesthetic type and amount. At the conclusion of the procedure, to maintain the blind, the patient will have a bandage placed where the QL block would have been performed.

干预措施: Local anesthetic infiltration (Procedure)

结局指标

主要结局

Pain Scores

时间窗: 0-48 hours after surgery ends

Using the Wong-Baker FACES Pain Rating Scale, patients will report their average pain from 0 hours post-op through 48-hours post-op at various intervals. In the Post-Anesthesia Recovery Unit, pain scores will be evaluated every 15 minutes as clinically able, until discharged from the PACU. On Post-Op Day 1 at 9:00 am, pains average pain score from discharge to PACU to midnight will be reported. At approximately 24-hours after surgery ends, pain scores from midnight to 23-hours post-op will be reported, then at the 48-hour post-op mark, pain scores from 24-hr post op to 48-hour post-op time will be recorded.

次要结局

  • Opioid Consumption up to 48 hours after surgery ends(From the pre-operative phase up to 48 hours after surgery ends)
  • Number of complications associated with each intervention(From the time the intervention is administered up to 48-hours after surgery ends.)
  • Time to block resolution(up to 7 days after surgery ends)

研究者

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

Nicole McCoy

Assistant Professor-Faculty

Medical University of South Carolina

研究点 (2)

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