Efficacy of Ultrasound-Guided Erector Spinae Plan Block on Postoperative Pain After Laparoscopic Cholecystectomy Under General Anesthesia. Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Morphine consumption
研究概览
简要总结
Laparoscopic cholecystectomy is a widely employed procedure in ambulatory surgery. Pain after laparoscopic cholecystectomy arises significantly from port site incisions in the anterior abdominal wall. Innervation of the anterior abdominal wall is segmentally supplied by pain afferents in the plane of fascia between transversus abdominis and the internal oblique muscles. Opioids analgesia is used to control postoperative pain, but it carries the risk of increased nausea and vomiting, ileus and sedation that may delay hospital discharge.
Several techniques have been tried as.neuroaxial narcotics, intraperitoneal lavage of local anesthetic and transversus abdominis plan (TAP) block and successfully reduced opioid use and improve postoperative analgesia.
The ultrasound-guided erector spinae plan(ESP) block is a recently described technique which produces reliable unilateral analgesia at thoraco-lumbar dermatomes. ESP block carries the advantages of being simple, safe, easily recognizable by ultrasound, and a catheter can be threaded to extend the duration of analgesia.
Few case series reported the efficacy of (US)-guided ESP blocks in reducing postoperative pain and opioids consumption.
Because of that, the investigators aimed to test the hypothesis that US-guided ESP blocks can decrease opioid consumption during the first 24 h after of laparoscopic cholecystectomy in comparison with the conventional systemic analgesia.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •60 ASA I- II adult patients
- •20-60 years old
- •elective laparoscopic cholecystectomy
- •Body mass index (BMI) less than 35
- •Port sites at or above thoracic T 10 dermatome
排除标准
- •Allergy to amino-amide local anesthetics
- •Presence of coagulopathy
- •Local skin infection at the needle puncture sites
- •Preoperative chronic dependence upon opioid and NSAID medications
- •Liver or renal insufficiency
- •History of psychiatric or neurological disease
- •previous open surgery that need the conversion of laparoscopic to open surgery or manipulations more than expected with more tissue trauma
- •American Society of Anesthesiologists (ASA) above Class II
研究组 & 干预措施
Group I (Control)
ultrasound guided Bilateral Erector Spinae Plan Block using isotonic saline
干预措施: Erector Spinae Plan Block (Procedure)
Group II (ESP)
ultrasound guided Bilateral Erector Spinae Plan Block with bupivacaine 0.25%
干预措施: Erector Spinae Plan Block (Procedure)
Group III(OSTAP)
Ultrasound-guided bilateral oblique subcostal TAP block
干预措施: Oblique subcostal TAP (Procedure)
结局指标
主要结局
Morphine consumption
时间窗: 24 hours postoperatively.
It was calculated as equivalent morphine dose to the opioid analgesia consumed
次要结局
- Quality of analgesia(Every 2 hours for 24 hours postoperatively)
- Erector spinae plan block complications(24 hours postoperative)
- The intraoperative fentanyl(2 hours)
- equivalent morphine dose in the recovery unit (PACU)(one hour)