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临床试验/NCT02346357
NCT02346357Unknown不适用

Ultrasound-Guided Obturator Nerve Block for Ambulatory Hip Arthroscopy: A Prospective, Randomized Controlled Trial

Benaroya Research Institute1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
70
试验地点
1
主要终点
Immediate pain score upon arrival to phase 1 PACU (NRS pain score)

研究概览

简要总结

Hip arthroscopy is commonly associated with moderate-to-severe postoperative pain. The purpose of this study is to investigate the analgesic efficacy of preoperative obturator nerve block as measured by postoperative pain scores and postoperative analgesic requirements. The primary outcome will be the patient's first reported pain scores in the post anesthesia care unit (PACU).

详细描述

RESEARCH DESIGN AND METHODS Patient selection The proposed study will be a prospective randomized placebo-controlled trial. Eligibility criteria will include patients having primary unilateral ambulatory hip arthroscopy for femoral acetabular impingement, age 18 to 65 years, ASA physical status I to III, and ability to follow the protocol.

Exclusion criteria: patient refusal, inability to comprehend the consent form, age < 18, and > 65 years of age; contraindications to obturator nerve blockade (pre-existing neuromuscular or peripheral nerve disorder, localized infection, or bleeding disorder); allergy to opioids or local anesthetics; allergy to celecoxib or sulfa medications or nonsteroidal anti-inflammatory medications (NSAIDs); chronic opioid use (> 1 month of 60 mg morphine PO equivalents daily); and, women who are pregnant or breastfeeding.

Consent Patients will be enrolled preoperatively in either the orthopedic surgery clinic or through the anesthesia preoperative clinic after the hip arthroscopy surgery is scheduled

Randomization, Blinding, and Allocation

Study medications will be administered by the primary investigator who will perform or closely supervise all ultrasound-guided obturator nerve blocks. Randomization will be performed with use of computerized random number generator and then each assignment will be placed into an opaque sealed envelope. Upon enrollment into the study and consent obtained, the next sealed envelope (numbered sequentially) will be opened and the patient allocated to either:

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

入选标准

  • Primary unilateral ambulatory hip arthroscopy
  • Age 18 to 65 years
  • ASA physical status I to III
  • Ability to follow the protocol.

排除标准

  • Age <18 or >65 years of age
  • Contraindications to peripheral nerve blockade
  • Allergy to opioids or local anesthetics
  • Allergy to sulfa medications or nonsteroidal anti-inflammatory medications
  • Chronic opioid
  • Patient refusal

研究组 & 干预措施

Obturator nerve block

Active Comparator

Ultrasound-guided single-injection obturator nerve block with 20 mL ropivacaine 0.5%

干预措施: Obturator Nerve Block (Procedure)

Obturator nerve block

Active Comparator

Ultrasound-guided single-injection obturator nerve block with 20 mL ropivacaine 0.5%

干预措施: Ropivacaine (Drug)

Sham block

Placebo Comparator

Placebo arm. Ultrasound-guided injection of 3-5 mL normal saline in the subcutaneous tissue in the same location as would for an obturator nerve block.

干预措施: Obturator Nerve Block (Procedure)

Sham block

Placebo Comparator

Placebo arm. Ultrasound-guided injection of 3-5 mL normal saline in the subcutaneous tissue in the same location as would for an obturator nerve block.

干预措施: Placebo Saline (Drug)

结局指标

主要结局

Immediate pain score upon arrival to phase 1 PACU (NRS pain score)

时间窗: Within 5-30 minutes upon leaving operating room and arrival to Phase I recovery

Initial NRS pain score upon arrival in the post anesthesia cafe unit (PACU)

次要结局

  • Post anesthesia care unit discharge (Time required to meet discharge criteria from phase 2 PACU)(Wihtin 6 hours from end of surgery.)
  • Nausea (Number of episodes of nausea and vomiting during the 1st 24 hours postoperatively)(1st 24 hours after surgery)
  • Sleep quality on on the day of surgery (Did subjects have difficulty going to sleep or wake up from sleep due to pain?)(Within 12-24 hours after discharge to home (from the hospital); typically the same night of the day of surgery.)
  • Opioid (analgesic) consumption(From the start of surgery to 24 hours after surgery complete (average surgical duration 2.5 hours).)
  • Pain scores for the 1st 24 hours after surgery (Numeric Rating Scale Pain)(1st 24 hours after completion of surgery.)

研究者

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

Francis V. Salinas , MD

Anesthesiologist

Benaroya Research Institute

研究点 (1)

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