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临床试验/NCT02623361
NCT02623361已完成4 期

A Prospective Analysis of Preoperative Fascia Iliaca Block for Hip Arthroscopy

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年2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
已完成
入组人数
80
试验地点
1
主要终点
Numeric Pain Score

研究概览

简要总结

Patients undergoing arthroscopic hip surgery have been shown to have significant post-operative pain that may delay discharge, recovery, and early mobilisation. A pre-operative regional anesthesia technique, the fascia iliaca block may be an effective method for acute post-operative analgesia.

This is a prospective, randomized controlled study of the preoperative fascia iliaca block for patients undergoing hip arthroscopy.

The enrolled patients will be randomized to receive either a fascia iliaca block with the local anesthetic ropivacaine or to have a sham block. All patients will receive a general anesthetic for the hip arthroscopy.

详细描述

Arthroscopic hip surgery is used to diagnose and treat interior joint pathology. Although minimally invasive in nature, patients have considerable amount of pain postoperatively, leading to prolonged recovery room stay and increased opiate requirements. The investigators performed a retrospective chart review in patients who underwent hip arthroscopy at the UCSF Orthopedic Institute. 89% of the patients had pain immediate after surgery requiring opioid therapy. Regional anesthesia has previously been shown to reduce discomfort after hip arthroscopy. However, there is currently no safe, well-established ultrasound guided regional anesthesia technique for arthroscopic hip surgery. The fascia iliaca block has shown to decrease acute pain related with hip fractures, as well as pain related with knee arthroplasty. The ultrasound guided fascia iliaca block is easy to perform and has an excellent safety record. The investigators believe that the ultrasound guided fascia iliaca block improves pain control in patients undergoing arthroscopic hip surgery.

Patients will receive a sham block group or a fascia iliaca block, performed in the preoperative area.

Pain scores and measurement of quadriceps strength will be assessed preoperatively and postoperatively. The patient will receive a pain diary consisting of pain scores, pain medication consumption, and a brief pain inventory. Within 48 hours postoperatively, an anesthesiologist will call the patient and review the patient's pain scores, pain medication consumption and brief pain inventory.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age at least 18 years old
  • American Society of Anesthesia physical classification I - III, scheduled for arthroscopic hip surgery

排除标准

  • Age younger than 18 years old
  • Non-English speaking
  • Contraindicated for regional nerve block (such as, but not limited to: coagulopathy, infection at site, allergy to local anesthetic)
  • Preexisting neurologic deficits of operative limb
  • Need for postoperative nerve function test
  • Inability to consent due to cognitive dysfunction
  • Chronic pain
  • Patient refusal.

研究组 & 干预措施

Fascia Iliaca Compartment Block

Active Comparator

干预措施: Peripheral Nerve Block (Drug)

Sham

Placebo Comparator

干预措施: Sham Block (Drug)

结局指标

主要结局

Numeric Pain Score

时间窗: within one hour after surgery

highest reported numeric score 0-10 in Post Anesthesia Care Unit (PACU) (primary endpoint) The NRS score is used to rate pain from 0 (no pain) to 10 (worst pain imaginable)

次要结局

  • Leg Strength at Discharge From Ambulatory Center, Surgical Leg(2 hours after surgery)
  • Patient Satisfaction(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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