Is External Oblique Intercostal Block Under Enhanced Recovery After Bariatric Surgery (ERABS) Superior to Oblique Subcostal Transversus Abdominus Block? A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- 24h equivalent oral morphine consumption
研究概览
简要总结
Laparoscopic bariatric procedures nowadays are employed under ERAS protocol as an ambulatory surgery. Pain after laparoscopic procedures arises significantly from port site incisions in the anterior abdominal wall, and shoulder pain (referred from visceral pain). Narcotic medications are utilized to manage postoperative pain, but its disadvantages include, increased post-operative nausea and vomiting (PONV), ileus, sedation and delayed hospital discharge.
Oblique subcostal transversus abdominis plane block (OSTAP) had been studied before and found to be effective in reducing post-operative morphine usage and produce good analgesia for about 24hours postoperatively.
The ultrasound-guided external oblique intercostal (EOI) block is a new technique which proved to produce unilateral analgesia at thoracic dermatomes supplying the anterior and lateral aspects of the upper abdomen.
The aim of this study was to test the hypothesis that US-guided EOI blocks can produce more reduction in opioid usage during the first 24 h after of laparoscopic bariatric surgeries when compared to oblique subcostal TAP (OSTAP) block.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age of 18 and 65;
- •American Society of Anesthesia (ASA) class II or III
- •elective laparoscopic bariatric procedure through trocars positioned at or above the um-bilicus (T10 dermatome).
排除标准
- •preoperative chronic use or contraindication to opioid or NSAID
- •allergy to bupivacaine
- •local skin infection at the injection site of EOI or OSTAP blocks
- •liver or renal insufficiency
- •psychiatric, or neurological disease
- •prior open abdominal surgery above T10 dermatome
- •patients converted to open surgery; and patients expected to be subjected to more tissue trauma.
研究组 & 干预措施
EOI group
Ultrasound-guided bilateral external oblique intercostal (EOI) using 30 ml of 0.25% bupivacaine hydrochloride and oblique subcostal transverse abdominis plane (OSTAP) block using Placebo (NSS 0.9%) 30 ml combined with bilateral posterior rectus sheath block with 15 ml bupivacaine 0.25%.
干预措施: External oblique intercostal block (Other)
EOI group
Ultrasound-guided bilateral external oblique intercostal (EOI) using 30 ml of 0.25% bupivacaine hydrochloride and oblique subcostal transverse abdominis plane (OSTAP) block using Placebo (NSS 0.9%) 30 ml combined with bilateral posterior rectus sheath block with 15 ml bupivacaine 0.25%.
干预措施: Posterior Rectus sheath block (Other)
OSTAP group
Ultrasound-guided bilateral oblique subcostal transverse abdominis plane (OSTAP) block using 30 ml of 0.25% bupivacaine hydrochloride and external oblique intercostal (EOI) using Placebo (NSS 0.9%) 30 ml combined with bilateral posterior rectus sheath block with 15 ml bupivacaine 0.25%.
干预措施: Oblique subcostal TAP block (Other)
OSTAP group
Ultrasound-guided bilateral oblique subcostal transverse abdominis plane (OSTAP) block using 30 ml of 0.25% bupivacaine hydrochloride and external oblique intercostal (EOI) using Placebo (NSS 0.9%) 30 ml combined with bilateral posterior rectus sheath block with 15 ml bupivacaine 0.25%.
干预措施: Posterior Rectus sheath block (Other)
结局指标
主要结局
24h equivalent oral morphine consumption
时间窗: 24 hour
Total pethidine consumption, calculated as an equivalent oral morphine dose, during the 24 hours,
Numerical rating scale (NRS)
时间窗: 24 hours
Numerical rating scale (NRS) in the PACU, and on arrival to the ward at 0 hours then at 2, 4, 6, 12, and 24 hours postoperatively(NRS) with 0 = no pain, to 100mm = the worst imaginable pain at the specified time.
次要结局
- Readiness for discharge(24 hours)
- Quality of recovery 40 score(QoR-40)(24 hours)
- AMBULATION TIME(24 hours)
研究者
Dr. Mohamed Ibrahim Elsayed
Anesthesia consultant
Al Mashfa Medical Center