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临床试验/NCT03506620
NCT03506620撤回4 期

The Role of Nerve Blocks in Hip Arthroscopy

Columbia University0 个研究点开始时间: 2019年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
主要终点
Pain Score

研究概览

简要总结

The goal of this study is to determine whether QL blocks reduce opioid consumption following arthroscopic hip surgery by decreasing postoperative pain. Considering the current opioid epidemic, the responsibility of physicians to help prevent addiction, and the increasing prevalence of arthroscopic hip surgeries, this study holds a tremendous potential benefit for future patients.

详细描述

The popularity of arthroscopic hip surgery has increased greatly over the last 10 years, particularly for correcting Femoroacetabular Impingement (FAI). FAI is a structural abnormality of the proximal femur, the acetabulum, or both. It is a leading cause of labral tears in the hip joint and can cause cartilage damage, which may increase subsequent risk of developing osteoarthritis. Though far less invasive than open hip surgery such as for a total hip replacement, hip arthroscopy can cause significant postoperative pain for the patient. Given how relatively new the procedure still is, methods of pain control are highly variable. Peripheral nerve blocks, mainly femoral nerve and lumbar plexus blocks, have been used by some surgeons to control postoperative pain. However, in addition to their sensory effects, these blocks cause motor impairment that has been associated with a significantly higher risk of falling.

In managing pain after any operation, opioid consumption is, of course, a significant concern. Ideally, hip arthroscopy patients could receive a peripheral nerve block that decreases pain and the need for opioids, but without the muscular weakness and increased fall risk observed with femoral nerve and lumbar plexus blocks. This may be achievable with the newer Quadratus Lumborum (QL) block.

The ultrasound-guided QL block is currently most commonly used for abdominal surgery.

However, several case studies of a single-injection QL block in hip replacement surgeries have been successful in minimizing pain and opioid use while sparing motor function and avoiding the muscle weakness that can lead to falls. In the approach utilized in these cases, local anesthetic was injected at the anterolateral border of the QL muscle to achieve analgesia ranging from the T6-T10 through L3 dermatomes. One group has anecdotally reported great success in using these QL blocks for alleviating postoperative pain with hip arthroscopy, but no studies to date have evaluated the effectiveness of QL blocks for arthroscopic hip surgery.

This study is a randomized, controlled, double-blind trial. Patients undergoing hip arthroscopy who agree to participate will be randomly selected to receive an ultrasound-guided QL block with either local anesthetic (QL block group) or normal saline (control group) preoperatively.

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, Care Provider)

盲法说明

The anesthesiologist, surgeon, and patient will all be blinded to the intervention. After patients consent to join the study, a member of the study team who is not involved in patient care will randomly allocate patients to 1 of 2 groups, the intervention or the controls. A statistician not involved with the study will creat a randomization table and coordinate with the Research Pharmacy to keep the study team blinded. Naropin (Ropivacaine) will be dispensed by the research pharmacy. The nurse will prepare the study injection accordingly for the blind anesthesiologist to administer. The QL block will be administered by a trained musculoskeletal regional anesthesia specialist before the standard induction of general anesthesia. The injection will occur under sedation to minimize discomfort for the patient. The QL block group's injection will consist of 20 cc of 0.25% Ropivacaine, whereas the control group will receive 20 cc of saline.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled to receive unilateral arthroscopy hip surgery at Columbia University Medical Center with Dr. Lynch.

排除标准

  • Patients scheduled to receive bilaterally or staged hip arthroscopy.
  • Patients unwilling to participate in the research.
  • History of chronic opioid use.
  • Contraindication or allergy to study medications, such as QL block.

研究组 & 干预措施

Control

Placebo Comparator

Subjects will be randomized to receive a single-injection QL block with normal saline (Saline Solution for Injection).

干预措施: Saline Solution for Injection (Drug)

QL Block

Experimental

Subjects will be randomized to receive a single-injection QL block with either local anesthetic (0.25% Ropivacaine injection).

干预措施: Ropivacaine injection (Drug)

结局指标

主要结局

Pain Score

时间窗: 7 days

Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)

Oral Morphine Equivalents

时间窗: 7 days after surgery

Opioid consumption following surgery as self reported by patients, measured in mg

Patient Satisfaction Score

时间窗: 7 days after surgery

Patients will record their satisfaction following surgery on a scale of 0-10 (0 being not satisfied, 10 being fully satisfied)

Percentage of Patients Reporting Nausea and/or Vomiting

时间窗: 7 days after surgery

Patients will self report any instances of nausea and/or vomiting

次要结局

  • HOS-ADL Questionnaire Score(2 weeks after surgery)
  • mHHS Questionnaire Score(2 weeks after surgery)
  • HOOS - Symptoms and Stiffness Questionnaire Score(2 weeks after surgery)
  • HOOS - ADL Questionnaire Score(2 weeks after surgery)
  • HOOS - Sports Questionnaire Score(2 weeks after surgery)
  • HOOS - Quality of Life Questionnaire Score(2 weeks after surgery)
  • UCLA Activity Score Questionnaire Score(2 weeks after surgery)
  • VR-12 Mental Health Questionnaire Score(2 weeks after surgery)
  • VR-12 Physical Health Questionnaire Score(2 weeks after surgery)
  • HOOS - Short Form Total Score Questionnaire Score(2 weeks after surgery)
  • iHOT-12 Questionnaire Score(2 weeks after surgery)
  • PROMIS v1.1 Pain Interference Questionnaire Score(2 weeks after surgery)
  • PROMIS v1.0 Pain Intensity 3a Questionnaire Score(2 weeks after surgery)
  • PROMIS v1.2 Physical Function Questionnaire Score(2 weeks after surgery)
  • PROMIS v2.0 Ability to Participate Socially Questionnaire Score(2 weeks after surgery)
  • PROMIS v2.0 Satisfaction with Roles and Activities Questionnaire Score(2 weeks after surgery)

研究者

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

Thomas Lynch

Assistant Professor of Orthopedic Surgery

Columbia University

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