The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy: A Blinded, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Physical Independence as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
研究概览
简要总结
The purpose of this study is to compare quality of recovery as well as peri-operative systemic opiates use and pain scores in patients undergoing laparoscopic or robotic hysterectomy when local anesthetic versus Quadratus Lumborum nerve block (QL-2) is added to the standard pain management.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English or Spanish speaking
- •American Society of Anesthesiologists (ASA) physical status 1-3
- •Planned laparoscopic or robotic hysterectomy
排除标准
- •History of chronic pain requiring preoperative opioids, Known alcoholism disorder
- •Congenital coagulopathy,
- •Localized soft tissue infection,
- •Use of anticoagulants,
- •Dementia, inability or refusal to provide consent for the surgery
- •Morbid obesity (BMI > 50), due to expected technical difficulty to achieve the block
研究组 & 干预措施
QL Block
干预措施: Sham Local (Drug)
QL Block
干预措施: QL (Drug)
Local Anesthesia at incision site
干预措施: Local anesthesia at incision site (Drug)
Local Anesthesia at incision site
干预措施: Sham QL (Drug)
结局指标
主要结局
Physical Independence as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
时间窗: 24 hours after anesthesia
The QOR-40 questionnaire has 5 questions assessing physical independence, with a maximum score of 25 and a minimum score of 5, with a lower score indicating a worst outcome.
Physical Comfort as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
时间窗: 24 hours after anesthesia
The QOR-40 questionnaire has 12 questions assessing physical comfort with a maximum score of 60 and a minimum score of 12, a lower score indicating a worst outcome.
Pain as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
时间窗: 24 hours after anesthesia
The QOR-40 questionnaire has 7 questions assessing pain with a maximum score of 35 and a minimum score of 5, a lower score indicating greater pain.
Psychological Support as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
时间窗: 24 hours after anesthesia
The QOR-40 questionnaire has 7 questions assessing Psychological support, with a maximum score of 35 and a minimum score of 7, with a lower score indicating a worst outcome.
Emotional State as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
时间窗: 24 hours after anesthesia
The QOR-40 questionnaire has 9 questions assessing emotional state, with a maximum score of 45 and a minimum score of 9, with a lower number indicating a worst outcome.
Quality of Recovery as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
时间窗: 24 hours after anesthesia
The QOR-40 questionnaire has 40 questions with a total score from 40 (poorest quality of recovery) to 200 (best quality of recovery), with a higher score indicating a better outcome
次要结局
- Pain at Dynamic as Assessed by the Visual Analog Scale(6 weeks post surgery)
- Time to Administration of First Pain Medication in PACU(From entry to Post anesthesia care unit (PACU) to time to administration of first pain medication in PACU (about 75 minutes))
- Number of Participants With Complications Related to a Study Intervention(30 days)
- Postoperative Nausea and Vomiting (PONV) Score Before Discharge(about 24 hours)
- Time Needed to Administer the Intervention QL Block(Time to administration of intervention QL block)
- Pain at Rest as Assessed by the Visual Analog Scale(6 weeks post surgery)
- Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)(6 weeks post surgery)
研究者
Randa Jalloul
Associate Professor
The University of Texas Health Science Center, Houston