Role of Co-administered Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section: A Randomized, Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Visual analog score for pain during movement
研究概览
简要总结
Our aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine 0.25% alone in transversus abdominis plane (TAP) block for postoperative analgesia in patients undergoing an elective Caesarean section.
- Group 1: bupivacaine 0.25% + dexamethasone 8 mg
- Group 2: bupivacaine 0.25% A prospective Randomized Interventional double-blind study.
详细描述
The pain and discomfort following cesarean delivery are mostly due to the abdominal wall incision and dissection of muscles; it delays early ambulation and breastfeeding. This can lead to postoperative complications such as thromboembolic disorders. So, providing an effective and safe postoperative analgesic method seems to be mandatory. Opioid analgesia remains the most effective means of relieving pain in a wide variety of conditions; however, it may cause adverse effects such as nausea, vomiting, pruritus, urinary retention, and respiratory depression. As the analgesia and the side effects of opioids are dose-dependent, a multimodal approach may enhance analgesia, which in turn would decrease the side effects .
Mc Donnell and colleagues have reported that a transversus abdominis plane (TAP) block can decrease the postoperative pain following abdominal surgery. The landmarks of this block were first described in 2001 by Rafi. The TAP block has been performed for postoperative analgesic control in patients undergoing radical prostatectomy, hysterectomy, cesarean delivery under spinal anesthesia, and laparoscopic surgery.
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)
盲法说明
Participating patients, surgeons, anesthesiologists and medical investigators who will be involved in the data collection will be all blinded to the patient's group assignment until the collection of data for all cases will be complete.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •healthy parturient (ASA I and II) scheduled to undergo LSCS under spinal anesthesia
排除标准
- •Participants had known sensitivity to bupivacaine
- •patient refusal,
- •localized infection over injection point
- •patients with significant coagulopathies and
- •with contraindications to regional anesthesia,
- •patients with heart diseases, altered renal or liver functions,
- •psychological disorders, patients with pregnancy-induced hypertension and
- •gestational diabetes, chronic use of pain medications,
研究组 & 干预措施
bupivacaine and dexamethasone
Bilateral TAP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.
干预措施: bupivacaine (Drug)
bupivacaine and dexamethasone
Bilateral TAP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.
干预措施: dexamethasone (Drug)
bupivacaine and placebo to dexamethasone
BilateralTAP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone
干预措施: bupivacaine (Drug)
bupivacaine and placebo to dexamethasone
BilateralTAP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone
干预措施: placebo to dexamethasone (Drug)
结局指标
主要结局
Visual analog score for pain during movement
时间窗: 6 hours post operative
movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain
次要结局
- number of patients need Fentanyl consumption(48 hours postoperative)
- number of days patients stay in hospital(4 weeks)
- Visual analog score during rest(48 hours postoperative)
研究者
hany farouk
Principal Investigator
Aswan University Hospital