Ultrasound-guided Transversus Abdominis Plane (TAP) Block Versus Local Wound Infiltration for Post-operative Analgesia After Cesarean Section Under General Anesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Postoperative pain severity assessed by the Numerical Rating Scale (NRS) pain score at 1,2,4,6, 12, and 24 hours
研究概览
简要总结
Adequate pain control after cesarean delivery is a major concern for both parturients and obstetrician, and it usually comprise a combination of systemic and regional techniques. The transversus abdominis plane (TAP) block, affecting the nerves supplying the anterior abdominal wall, is a recently introduced, promising regional analgesic technique for a variety of abdominal and pelvic surgeries including cesarean delivery .
Infiltration of local anesthetic into the surgical wound (either as a single shot or using indwelling catheters) has long been used for postoperative analgesia, Both the TAP block and wound infiltration, are superior to placebo, however, it is unknown which of them provides better analgesia after cesarean delivery because of a scarcity of randomized clinical trials.
This study aimed to compare bilateral US guidedTAP block with single-shot local anesthetic wound infiltration for analgesia after cesarean delivery performed under general anesthesia. The investigators hypothesized that the TAP block would decrease postoperative cumulative opioid consumption at 24 hours.
详细描述
The Anaesthesilogist is Senior staff trained on such procedure.
- Pre-operative settings
- The study subjects will randomly assigned to 3 equal groups (TAP group, infiltration group and narcotics only group ) using a computer-generated table of random numbers. A single investigator will assess the patients for eligibility, obtained written informed consent, and record the baseline data for each participant before delivery. Sequentially numbered, sealed opaque envelopes containing group allocation will be opened by the primary investigator after administration of general anesthesia . Neither the study subjects nor the outcome assessors knew the study group
- Routine preoperative investigations will be done to all patients including laboratory investigations as (complete blood picture, liver function tests, prothrombin time and partial thromboplastin time).
- Demographic data as age, weight, will be recorded.
All mothers who scheduled for elective cesarean delivery who fulfilled inclusion criteria and volunteer are assessed by:
Postoperative pain by Numerical Rating Scale (NRS) pain score (range, 0-10; 0, no pain; 10, worst pain) on arrival in the post-labor ward (time 0) and at 2,4,6, 8, 12,18 and 24 hours postoperatively.
The duration of block (defined as the interval between performing the block and the time of the first request for analgesia) and total pethidine consumption were recorded in the 24 hours after surgery The level of patient satisfaction was measured numerically by a Likert scale ranging from one to five, 1: "not satisfied at all," 2: "slightly satisfied," 3: "moderately satisfied," 4: "very satisfied," and 5: "highly satisfied". Any adverse effects or complications will be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •• Patients undergoing elective cesarean section under general anathesia
- •Pfannenstiel Skin Incision
- •Age between 18 and 40 years old
- •BMI between 18 and 35 kg/m2
排除标准
- •• Patient refusal.
- •BMI<18 kg/m2 or>35 (require different dose of analgesia)
- •Height <150 or > 180 cm (require different dose of analgesia)
- •Patients with any neurological deficit due to neuropathy and pain score affection
- •Patients with bleeding disorders which may lead to hematoma
- •HTN (Vasculopathy which can lead to hematoma).
- •Cardiac disease ( Vasculopathy on anticoagulant which can lead to hematoma)
- •DM (decrease systemic and local immunity which can lead to abscess at injection site and due to neuropathy and pain score affection).
- •Liver disease (defective clotting factors).
- •A history of relevant drug allergy or Hypersensitivity to any of the drugs used in the study due to impair of proper follow up of pain postoperative
- •History of recent opioid exposure due to affection on pain score
- •Local skin infection due to abscess formation
- •Obstetric complications e.g placenta previa and rupture uterus due to extensive tissue damage and dissection
结局指标
主要结局
Postoperative pain severity assessed by the Numerical Rating Scale (NRS) pain score at 1,2,4,6, 12, and 24 hours
时间窗: 24 hours after the procedure
Assessment of pain involves asking a patient to rate her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 equal to the worst possible pain after first hour, 2nd hour,4th hour, 6th hour, 12th hour and 24th hour at wards after end of surgery.
The duration of analgesia achieved by each type of block assessed by the time of first postoperative pethidine dose required.
时间窗: 24 hours after the procedure
By asking the patients about the first time to analgesic request
次要结局
- the incidence of side effects and Toxicity (nausea and vomiting and pruritis).(24 hours after the procedure)
- Cumulative pethidine consumption at 2, 4, 6, and 12 hours, NRS at 0, 4, 6, 12, and 24 hours.(24 hours after the procedure)
- Patient Satisfaction(24 hours after the procedure)
研究者
Mostafa R Bakry, Master's Degree
The principal investigator
Ain Shams Maternity Hospital