Transmuscular Quadratus Lumborum Block Plus Pericapsular Injection vs Pericapsular Injection for Patients Undergoing Primary Hip Arthroscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Comparison of post-operative pain as per the Visual Analogue Scale (VAS)
研究概览
简要总结
The purpose of this research study is to compare two different treatment options on their effectiveness to reduce post-operative pain, narcotic (opioid pain medication) usage and recovery time in patients undergoing primary hip arthroscopy surgery.
The first treatment option is a Transmuscular Quadratus Lumborum (TQL) block plus hip incision site (Pericapsular) Injection. The TQL block is an ultrasound guided injection between the quadratus lumborum and the psoas muscles in the back. The anesthesiologist will perform the TQL block The second treatment option is only a hip incision site (Pericapsular) Injection. In this group, the surgeon will inject local anesthetic into the incision or hip portal sites to decrease sensation.
详细描述
This is a phase IV, randomized, single-blind, single-center study comparing postoperative pain, opioid usage and Post-Anesthesia Care Unit (PACU) recovery time for patients who receive a Transmuscular Quadratus Lumborum block (TQLB) plus pericapsular injection versus pericapsular injection (PCI) undergoing primary hip arthroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- 否
入选标准
- •Patients between 18 and 65 years of age
- •Patients undergoing Primary Hip Arthroscopy
- •Patients diagnosed with femoroacetabular impingement (FAI)
- •Patients who consent to be randomized.
排除标准
- •Patients younger than 18 and older than 65;
- •Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer;
- •Patients with diagnosed or self-reported cognitive dysfunction;
- •Patients with a history of neurologic disorder that can interfere with pain sensation;
- •Patients with a history of drug or recorded alcohol abuse;
- •Patients who are unable to understand or follow instructions;
- •Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
- •Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
- •Patients with BMI over 40;
- •Any patient that the investigators feel cannot comply with all study related procedures.
研究组 & 干预措施
Pericapsular Injection (PCI) group
Subjects in PCI group will receive the injection through both hip portals administered by the surgeon. 10 mL of 0.25% Bupivacaine Hydrochloride (HCL) will be injected through the anterolateral portal while the additional 10 mL will be injected through the mid-anterior portal.
干预措施: Pericapsular injection (Procedure)
Pericapsular Injection (PCI) group
Subjects in PCI group will receive the injection through both hip portals administered by the surgeon. 10 mL of 0.25% Bupivacaine Hydrochloride (HCL) will be injected through the anterolateral portal while the additional 10 mL will be injected through the mid-anterior portal.
干预措施: Bupivacaine Hydrochloride (Drug)
Transmuscular QL Block + Pericapsular Injection (PCI) group
Subjects in the TQLB group will receive the TQLB containing 30mL of 0.5% Bupivacaine Hydrochloride (HCL) plus PCI containing 20 mL of 0.25% of Bupivacaine Hydrochloride (HCL). For PCI, subjects will receive the injection through both hip portals administered by the surgeon. 10 mL of 0.25% Bupivacaine Hydrochloride (HCL) will be injected through the anterolateral portal while the additional 10 mL will be injected through the mid-anterior portal.
干预措施: Transmuscular Quadratus Lumborum Block (Procedure)
Transmuscular QL Block + Pericapsular Injection (PCI) group
Subjects in the TQLB group will receive the TQLB containing 30mL of 0.5% Bupivacaine Hydrochloride (HCL) plus PCI containing 20 mL of 0.25% of Bupivacaine Hydrochloride (HCL). For PCI, subjects will receive the injection through both hip portals administered by the surgeon. 10 mL of 0.25% Bupivacaine Hydrochloride (HCL) will be injected through the anterolateral portal while the additional 10 mL will be injected through the mid-anterior portal.
干预措施: Pericapsular injection (Procedure)
Transmuscular QL Block + Pericapsular Injection (PCI) group
Subjects in the TQLB group will receive the TQLB containing 30mL of 0.5% Bupivacaine Hydrochloride (HCL) plus PCI containing 20 mL of 0.25% of Bupivacaine Hydrochloride (HCL). For PCI, subjects will receive the injection through both hip portals administered by the surgeon. 10 mL of 0.25% Bupivacaine Hydrochloride (HCL) will be injected through the anterolateral portal while the additional 10 mL will be injected through the mid-anterior portal.
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
Comparison of post-operative pain as per the Visual Analogue Scale (VAS)
时间窗: 1 Day of surgery
This will be measured by using Visual Analogue Scale (VAS) pain scores and compared between the 2 treatment groups after surgery. The distribution of pain Visual Analogue Scale (VAS) scores in post- surgical patients will describe their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain Visual Analogue Scale (VAS) have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Comparison of post-operative pain as per the McGill pain scores
时间窗: 1 Day of surgery
This will be determined by the McGill Pain questionnaire (MPQ) scores and compared between the 2 treatment groups during the post-operative period. The MPQ assesses three separate components of the pain experience: the sensory intensity, the emotional impact and the cognitive evaluation of pain. Each descriptor is ranked on a 0 ("none") to 3 ("severe") intensity scale.
次要结局
- Comparison in Post-Anesthesia Care Unit (PACU) Phase 1 recovery time by treatment group(1 Day of surgery)
- Use of Opioids by participants(1 Day of surgery)