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临床试验/NCT06102811
NCT06102811招募中不适用

Low Concentration Local Anesthesia Fascia Iliaca Block for Total Hip Arthroplasty

University of Toronto2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月23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
60
试验地点
2
主要终点
Quadriceps muscle strenght

研究概览

简要总结

Fascia iliaca compartment block (FICB) is a documented option for postoperative analgesia for total hip arthroplasty (THA) surgery. FICB is demonstrated to be effective in terms of analgesia and opioid requirements decrease, however it causes quadriceps motor weakness. Current available motor sparing techniques are not as effective as FICB for analgesia. Low concentration local anesthetics (LCLA) are used with excellent results for pain control with no or minimum motor block effect, in other scenarios (highlighted in obstetric anesthesia) and techniques (epidural anesthesia, for instance). This study proposes that LCLA-FICB can offer the benefit of peripheral nerve blocks mediated analgesia, while at the same time avoiding motor blockade and muscle weakness. The investigators hypothesize that LCLA-FICB, when compared to conventional high concentration local anesthetics (HCLA) FICB, provides similar postoperative analgesia in the first 24 hours following primary THA, while at the same time preserving quadriceps muscle group strength.

详细描述

Significance There are no published prospective randomized controlled trials evaluating LCLA blocks for THA. As THA is the second most frequent type of surgery requiring hospitalization, and has the prediction to increase its incidence for the next years, there is significant importance in investigations about interventions which may improve its recovery in an outpatient regime. A postoperative analgesic technique that offers better pain control, has less adverse effects, reduces the opioid analgesia requirement and is safer, may have additional impact on decreasing health care costs, and may lead to an enhanced recovery and better quality of life for THA patients.

Objectives The primary objective will be to evaluate efficacy of LCLA-FICB in comparison to HCLA-FICB for patients undergoing primary THA, in terms of pain scores and opioid consumption.

The secondary objective is to assess postoperative opioid related side effects and ipsilateral quadriceps weakness between those two postoperative analgesia techniques.

Hypothesis The LCLA-FICB, in comparison to HCLA-FICB, provides non-inferior postoperative analgesia in the first 24 hours following primary THA, while at the same time preserving quadriceps muscle group strength.

Methods Study type This will be a randomized controlled prospective trial, blinded for patient and evaluator, in patients undergoing primary THA at Sinai Health. After Hospital's Ethics in Research Board approval, the recruitment will begin. Patients will be assessed about their eligibility for participating and after plain clear information about the study interventions they will or will not authorize their inclusion and data collection, through the signature of a written consent.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Patients undergoing primary THA in the inpatient setting.
  • Non-pregnant patients older than 21 years of age.
  • Patients with American Society of Anesthesiologists (ASA) physical status I-IV.
  • No alcohol or drug dependency.

排除标准

  • Patients undergoing outpatient THA.
  • Chronic opioid use of 30 mg or more of oral morphine equivalent, per day, for the last 2 consecutive weeks.
  • Contraindications for nerve block placement (severe anatomic abnormalities, local or systemic infection).
  • Contraindications for any of the standardized medications used for the study (Mepivacaine, Fentanyl, Dexamethasone, Ondansetron, Acetaminophen, Celecoxib, Hydromorphone).
  • Not submitted to the standardized spinal anesthesia technique.
  • Need to conversion to general anesthesia after the start of the surgery.

研究组 & 干预措施

Low Concentration Local Anesthetic Fascia Iliaca Compartment Block

Experimental

Patients will be submitted to a Suprainguinal Fascia Iliaca Block with low concentration local anesthetic (Ropivacaine 0.075%)

干预措施: Low Concentration Local Anesthetic Fascia Iliaca Compartment Block (Other)

High Concentration Local Anesthetic Fascia Iliaca Compartment Block

Active Comparator

Patients will be submitted to a Suprainguinal Fascia Iliaca Block with high concentration local anesthetic (Ropivacaine 0.25%)

干预措施: High Concentration Local Anesthetic Fascia Iliaca Compartment Block (Other)

结局指标

主要结局

Quadriceps muscle strenght

时间窗: 4 hours after spinal anesthesia

Intensity of quadriceps strength: Muscle Strength Grading (Oxford Scale): 0 - no muscle activation; 1 - trace muscle activation, such as a twitch, without achieving full range of motion; 2 - muscle activation with gravity eliminated, achieving full range of motion; 3 - muscle activation against gravity, full range of motion; 4 - muscle activation against some resistance, full range of motion; 5 - muscle activation against examiner's full resistance, full range of motion.

次要结局

  • Pain scores(24 hours after spinal anesthesia)
  • Opioid consumption(24 hours after spinal anesthesia)

研究者

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

Hermann dos Santos Fernandes

Assistant Professor

University of Toronto

研究点 (2)

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