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临床试验/NCT04538105
NCT04538105撤回不适用

Preoperative Fluoroscopy Guided Hip Articular Branch Blocks and Analgesic Outcomes Following Hip Arthroscopy: A Randomized, Controlled Trial

Rush University Medical Center0 个研究点开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
NRS Pain Scores (NRS)

研究概览

简要总结

Arthroscopic hip surgeries are increasingly being performed as both diagnostic and therapeutic interventions. These procedures are considerably painful, thus requiring the proper pain management techniques in order to provide patient satisfaction and sufficient pain control. Articular branch blocks have not been evaluated for their use in hip arthroscopy, but have potential advantages of blocking the sensory innervation of the entire hip joint, with minimal impact on motor innervation compared to alternative blocks.

This current study aims to evaluate the efficacy of using preoperative fluoroscopic-guided blockade of articular branches of the femoral and obturator nerves for analgesic management of patients undergoing arthroscopy compared to a saline sham block.

The utility of pre-operative hip articular branch block (ABB) prior to hip arthroscopy will provide superior pain management postoperatively compared to a saline sham block. We hypothesize that the ABB (Articular Branch Block) will reduce the area under the NRS pain scores by time curve (AUC) and decreased oral opioid milligram equivalent use in the first 24 hours post-operatively.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presenting for Hip Arthroscopy (Diagnostic or Therapeutic)
  • Pre-operative Numeric Rating Score (NRS) for pain <8 on a 0 to 10 scale where 0 is no pain and 10 is worst pain imaginable.

排除标准

  • Allergies to any of the study medications
  • Anti-coagulation status (INR > 1.1, PT or APTT > 1.5 control)
  • History of Hip Arthroplasty
  • Infection of Hip
  • Evidence of tumor
  • Pregnancy
  • History of diabetes with HbA1c > 10%
  • Prior history of Hip Articular Branch Blockade or Hip Articular Branch PRF Ablation

结局指标

主要结局

NRS Pain Scores (NRS)

时间窗: 24 hours post-operatively

Numerical Rating Scale is a self-reported pain assessment, in which a patient indicates their current pain level experienced. Patients can rate their pain on a scale of 0 (no pain) to 10 (worse pain imaginable). Higher scores indicated on this scale may indicate that a patient is experiencing higher pain intensities at that particular point in time. Whereas lower reported scores indicate that the patient is experiencing less intense or minimal pain.

次要结局

  • Analgesic medication use(24 hours post-operatively)
  • The QOR-15 (Quality of Recovery)(24 hours post-operatively)

研究者

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

Tolga Suvar, MD

Principle Investigator

Rush University Medical Center

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