Analgesic Efficacy of Quadaratus Lumborum Block (QLB) for Laparoscopic Colectomy Surgery: A Prospective Observational Case Control Trial to Evaluate Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Verbal analogue scale (VAS)
研究概览
简要总结
Pain after abdominal surgery can be extensive. Pain control is an important component of patient comfort and participation in rehabilitation. Multimodal analgesia methods have shown to reduce postoperative pain, and have been addressed to be a crucial part of the Enhanced Recovery after Surgery (ERAS) protocols.
Quadratus lumborum block (QLB) is a posterior abdominal wall block which analgesic efficacy has been shown for abdominal surgeries, and also for different laparoscopic procedures, such as ovarian surgery.
The aim of this study is to assess QLB's analgesic efficacy for laparoscopic colectomy surgeries, using serial pain score assessments and overall opioid consumption; its effect on patient satisfaction; and its effect on the development of postoperative respiratory complications. This study is a prospective clinical trial assessing the effect of application of QLB as a regional analgesic technique for primary laparoscopic colectomy, in comparison to a historical retrospective cohort.
详细描述
A. Specific Aims Pain control is an important component of patient comfort and rehabilitation after surgery. The aim of the study is to improve multimodal analgesia and reduce postoperative pain for laparoscopic colonic surgery. We hypothesize that performing a Quadratus Lumborum Block (QLB) prior to start of laparoscopic colon surgery will provide significant analgesic effect. As such, the primary endpoint of this study is the patient's maximal reported pain scores using a numeric verbal analogue scale (1-10) elicited during the patient's post operative recovery unit (PACU) stay, 24 hours, 48 hours and 4 weeks after surgery.
Secondary endpoints are:
- Total opioid consumption during PACU stay and on 24 hours ,48 hours and 4 weeks after surgery.
- Length of hospital stay
- Overall patient satisfaction - will be documented on 24 hours after surgery, 48 hours and 4 weeks after surgery.
- Minimal saturation during PACU stay
- Development of postoperative respiratory complications until patient discharge: re-intubation, documented apneas, severe hypoxemia (measured saturations <94%; or arterial blood oxygen partial pressure in relation to inspired oxygen concentration [PaO2/FiO2] ration below 200)
Research Design and Methods The study is a prospective clinical trial assessing the effect of application of QLB as a regional analgesic technique for primary laparoscopic colectomy, in comparison to a historical cohort.
Inclusion Criteria:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All primary laparoscopic colectomy patients are eligible for inclusion in the study.
排除标准
- •Previous abdominal surgery
- •Allergy to local anesthetics or to systemic opioids
- •Contraindication to regional anesthesia technique, such as local infection or coagulopathy, or patients receiving anticoagulation therapy with smaller specifications than listed in professional guidelines.
- •Contraindication to the Quadratus lumborum block such as defects or interferences in the abdominal wall obstructing anatomical structure visibility.
- •Requirements of more than 30 mg morphine equivalent daily prior to surgery
- •ASA IV or greater
- •Psychiatric or cognitive disorders
- •Incarceration
- •Renal insufficiency with Cr > 2.0
- •Hepatic failure
- •Pregnancy
- •Age under 18 years
结局指标
主要结局
Verbal analogue scale (VAS)
时间窗: 48 hours
patient's maximal reported pain scores using a numeric verbal analogue scale (1-10) on postoperative day 2
次要结局
- Total opioid consumption postoperative day 2(48 hours)
- Total opioid consumption in PACU(24 hours)
- Total opioid consumption on postoperative day 1.(24 hours)
- Total opioid consumption at four weeks postoperatively(4 weeks)
- Length of hospital stay(1 week)
- Quality of recovery score (questionaire) four weeks postoperatively(4 weeks)
- Quality of recovery score (questionaire) 1 day postoperatively(24 hours)
- Quality of recovery score (questionaire) 48 postoperatively(48 hours)
- Minimal saturation during PACU stay(24 hours)
- Development of postoperative respiratory complications until patient discharge(1 week)