The Efficacy of Transversus Abdominis Plane Block Versus Wound Infiltration for Analgesia After Cesarean Delivery: (A Randomized Controlled Double-blinded Clinical Trial )
试验速览
- 阶段
- 不适用
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- The degree of pain at rest ;
研究概览
简要总结
This study aimed to compare bilateral ultrasound-guided TAP block with single-shot local anesthetic wound infiltration for analgesia after cesarean delivery performed under spinal anesthesia
详细描述
This double-blind, randomized controlled trial aimed to compare bilateral ultrasound-guided TAP block to single-shot local anesthetic wound infiltration for analgesia after cesarean delivery performed under spinal anesthesia. This will be done by measuring VAS (visual analogue score) for pain after ceserian section at2, 4, 6, 12, 24 hours .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
computer-generated table of random numbers
入排标准
- 年龄范围
- 19 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing cesarean section under spinal anesthesia
- •Aged ≥19 years and > 40 years .
- •Gestational age ≥ 37 Weeks .
- •Informed Consent From the Patient .
排除标准
- •Body mass index (BMI) ≥40 kg/m2 ..
- •History of recent opioid exposure .
- •Hypersensitivity to any of the drugs used in the study .
- •Significant cardiovascular, renal, or hepatic disease.
研究组 & 干预措施
In the TAP group (Group A )
after completion of surgery, bilateral ultrasound-guided TAP block was performed .
Description of the intervention: a 12-4-MHz linear array transducer (ClearVue 350; Philips, Bothell, WA) placed transversely between the iliac crest and costal margin in the anterior axillary line and slid medial-lateral to visualize the external oblique, internal oblique, and trans-versus abdominis muscles; the most lateral (posterior) position obtaining a satisfactory ultrasound image was used ;A 22-gauge spinal needle was introduced from medial to lateral in-plane to the ultrasound probe, and 20 mL of bupivacaine 0.25% was injected under visualization in the plane between the transversus abdominis muscle and the fascia deep to the internal oblique muscle on each side.
干预措施: TAP block (Device)
In the infiltration group (Group B )
at the end of surgery, 40 mL of bupivacaine 0.25% was injected subcutaneously in the surgical wound (20 mL in each of the upper and lower sides) by the obstetrician before skin closure.
干预措施: TAP block (Device)
In placebo group (Group C )
routine analgesic was administered and recorded .
干预措施: TAP block (Device)
结局指标
主要结局
The degree of pain at rest ;
时间窗: From 2 hours to 24 hours postoperatively
using an Visual analogue scale (VAS) scores for pain intensity reported on 0-10 point scale for analysis. (0 = no pain and 10 = the worst possible pain) .
次要结局
- The time to the first postoperative opioid dose(at 2, 4, 6, and 12 hours.)
研究者
Mohamed Hassan Mohamed Mostafa
Clinical professor
Ain Shams University