Comparison of Subcostal Transversus Abdominis Block With Intraperitoneal Instillation of Bupivacaine and Dexmedetomidine for Pain Relief After Laparoscopic Cholecystectomy: A Randomized Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The intensity of postoperative pain
研究概览
简要总结
Pain after laparoscopic cholecystectomy is common and may lead to delayed hospital discharge.
详细描述
Laparoscopic cholecystectomy (LC) is very commonly performed nowadays, and it has now completely replaced open cholecystectomy in the management of biliary lithiasis. Although it is minimally invasive surgery, pain in postoperative period is always major concern as it increases perioperative stress, morbidity, and hospital stay.
There are two components involved in pain after LC; the visceral component is due to tissue damage in anterior abdominal wall during the insertion of trocar and shoulder tip pain due to diaphragmatic irritation caused by Spillage of blood or bile and peritoneum stretching caused by pneumoperitoneum.
There are several methods employed in the management of postoperative pain after LC such as conventional systemic analgesics, including paracetamol, non-steroidal anti-inflammatory drugs, systemic opioids, thoracic epidural analgesia, low-pressure pneumoperitoneum, and warm air with all having its side effects .
Transversus abdominis plane (TAP) block has got a substantial role in postoperative analgesia after abdominal surgery because deposition of local anesthetics in transversus abdominis fascial plane can produce sensory block over the anterior abdominal wall from T7 to L1. Many clinical studies reported beneficial effects of TAP but results were mainly connected to lower abdominal surgery. Since the major part of pain after LC derives from abdominal wall incisions, some trials investigated TAP block as potential analgesic option. Some studies showed that TAP block can reduce opioid requirements and pain scores but the results were not conclusive enough because many differences in study designs.
The ultrasound-guided (USG) subcostal transversus abdominis plane block (STAP), first described by Hebbard 2008, is a variation of TAP which successfully solve the problem of unreliable supraumbilical distribution of the block. Results obtained in a few small studies showed significantly better analgesia after LC compare to traditional opioid analgesia, port-site infiltration and standard TAP.
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 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective LC under general anesthesia, aged from 20 to 65 years old.
排除标准
- •Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis)
- •Altered conscious level
- •Pregnancy
- •Body mass index (BMI > 35)
- •Patients who have difficulty understanding the study protocol 6- Patients who have any known contraindication to study medications 7- Patient refusal.
研究组 & 干预措施
Group I
Patients will receive USG-STAP block with bupivacaine and dexmedetomidine in both sides ten minutes before skin incision and intraperitoneal normal saline.
干预措施: USG-STAP with bupivacaine and dexmedetomidine (Drug)
Group II
Patients will receive bupivacaine and dexmedetomidine through the intraperitoneal route and USG-STAP block with normal saline at the end of surgery
干预措施: IP bupivacaine and dexmedetomidine (Drug)
结局指标
主要结局
The intensity of postoperative pain
时间窗: 24 hours after surgery
Assessed by the numerical rating pain scale (NRS)
次要结局
未报告次要终点
研究者
Seham Mohamed Moeen Ibrahim
Assiut University
Assiut University
