Effectiveness of Bilateral Erector Spinae Plane Block (ESPB) in Laparoscopic Colectomies -A Randomized, Controlled, Double Blind, Prospective Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mobilization Time
研究概览
简要总结
The aim of the trial is to study the efficacy of continuous bilateral Erector Spinae Plane Block (ESPB) in managing perioperative pain in patients who undergo elective laparoscopic colectomy.
详细描述
Laparoscopic colectomy is a common surgery performed by general surgeons for a variety of reasons, such as colon cancer, inflammatory bowel disease, multiple precancerous colon polyps. Nowadays, due to the evolution of laraposcopic techniques, laparoscopic colectomies are performed with minimally invasive procedures. However, most patients complain for moderate to severe post-operative pain, which requires the application of multimodal analgesia recipes and the administration of large doses of opioids perioperatively, in order to be relieved. Due to the opioid crisis observed in the U.S. and in many european countries and due to the variety of adverse effects observed after the administration of opioids (respiratory depression, nausea, vomiting, delayed mobilization of gastrointestinal system and the patient), which augment not only the hospitalization time but also the hospitilization cost of the patients, anesthesiologists tend to limit their administration, especially in colectomies.
Erector Spinae Plane Block (ESPB) is an innovating trunk block, which was first described in 2016 by Forrero et. al in order to relieve neuropathic pain. Since then, it was embraced by modern anesthesia practices and is currently effectively performed for chronic pain, acute post-traumatic and acute post-operative pain, in various surgical procedures. Specifically, ESPB has been performed for the treatment of thoracic neuropathic pain, of acute post-operative pain after thoracotomy, laparoscopic cholecystectomy, total hip arthroplasty, modified radical mastectomy, emergent laparotomy and after various surgical procedures of the spine, with good results.
There are no clinical trials that study the effectiveness of continuous bilateral Erector Spinae Plane Block in laparoscopic colectomies.
This trial is a randomized, controlled, double - blind, prospective trial, predominantly aiming at evaluating the effectiveness of continuous bilateral Erector Spinae Plane Block (ESPB) in managing perioperative pain in patients who undergo elective laparoscopic colectomy.
This trial will recruit 40 patients (men and women), aged 18 to 85 years old who will undergo laparoscopic colectomy, performed by the same experienced, surgical team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I, II, III Laparoscopic colectomy Elective surgery
排除标准
- •Patient refusal Known allergies to local anesthetics Other contraindications to regional anesthesia Infection or anatomic anomalies on injection site Uncontrolled hypertension Severe liver or kidney disease Pregnancy Known depression or psychiatric disorders, dementia Drug or alcohol abuse Inadequate command of Greek language
研究组 & 干预措施
Ropivacaine Group
ESPB performed with infusion of Ropivacaine 0,375% (20 ml at ech side)
干预措施: Ropivacaine injection (Drug)
Control Group
ESPB performed with infusion of N/S 0,9% (20 ml at each side)
干预措施: Ropivacaine injection (Drug)
结局指标
主要结局
Mobilization Time
时间窗: In a time frame of up to 72 hours Post - Operatively
Time of Mobilization of the gastrointestinal tract and of the patient
Total Perioperative Tramadol Consumption
时间窗: 96 hours after surgery
Total Perioperative Tramadol Consumption
Start of Oral Fluids and Nutrition
时间窗: In a time frame up to 72 hours Post - Operatively
Time of start of oral fluids and enteral nutrition
Satisfaction from Perioperative Analgesia
时间窗: 96 hours post - operatively
Satisfaction Score of the patient regarding perioperative analgesia, using a numerical rating scale from 1 to 6, where "1" means not satisfied at all and "6" means completely satisfied.
Hospitalization Days
时间窗: In a time frame up to 2 Weeks Post - Operatively
Duration of hospital stay after surgery in days
Quality of Recovery
时间窗: 72 hours Post - Operatively
Quality of Recovery-15 \[(QoR) -15\] Questionnaire. A questionnaire which consists of 15 questions in two Parts, rated from 0 to 10 ("0" is the worst and "10" is the best answer). The worst overall score is 0 and the best overall score is 150.
次要结局
- Pain Score, Post Operative Nausea and Vomiting Score 12 hours post-operatively(12 hours post - operatively)
- TNF-a, IL-1, IL-6 levels post-operatively(Pre-operatively and the 1st and 4th day post-operatively)
- Pain Score, Post Operative Nausea and Vomiting Score 24 hours post-operatively(24 hours post - operatively)
- Pain Score, Post Operative Nausea and Vomiting Score 36 hours post-operatively(36 hours post - operatively)
- Pain Score, Post Operative Nausea and Vomiting Score 48 hours post-operatively(48 hours post - operatively)
- Pain Score, Post Operative Nausea and Vomiting Score at discharge from Post-Anesthesia Care Unit (PACU)(Immediately Post - Operatively)
- Total Desflurane Consumption(Intra - Operatively)
- Total Remifentanyl Consumption(Intra - Operatively)
- Post Anesthesia Care Unit (PACU) Duration of stay(Immediately post-operatively)
- Total Cost(Perioperatively)
研究者
Freideriki Sifaki
M.D., Msc
Democritus University of Thrace