Comparison of Impact of Intrathecal Morphine With Ultrasound-guided Transversus Abdominis Plane Block on Patient Reported Quality Of Recovery following elective Caesarean delivery : A Non-Inferiority Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the quality of recovery at 24 hours post cesarean delivery, measured by the total ObsQoR-11Hindi score, between patients randomized to receive ITM versus those randomized to receive TAP block, within a non-inferiority framework.
研究概览
简要总结
Low dose ITM (50-100 mcg) has been recommended by various guidelines as postoperative analgesic technique after CS, as part of multimodal analgesia regimen. But its use is still not prevalent worldwide, due to its bothersome side effects, pruritus and nausea and vomiting. When compared to ITM, TAP has been found to have comparable or slightly less effective analgesia(on the basis of time to fist rescue analgesia), but is associated with a better side-effect profile. Therefore, within the multimodal analgesia framework, we aim to compare the two to explore whether TAP leads to a non inferior overall quality of recovery (QoR). If TAP block demonstrates non-inferior QoR, it provides a valuable alternative to the standard treatment of ITM, as a part of post-cesarean multimodal analgesia regimen, especially for patients at high risk for opioid side effects (e.g., OSA, severe PONV/pruritus history) and in settings where long-acting opioids cannot be used due to paucity of resources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Parturients more than 18 years undergoing elective caesarean delivery under spinal anesthesia.
- •ASA physical status II-III.
- •Able to provide informed consent & complete questionnaire in Hindi.
排除标准
- •Patient refusal Contraindication to spinal anesthesia, ITM or TAP block General anesthesia planned/required Chronic opioid use Significant hepatic/renal impairment Coagulopathy BMI more than 40 kg/m² Patient at extremes of height.
- •Active infection at injection sites Medical illness which requires admission high dependency unit Medical barrier which would prevent patient from completing the ObsQoR form.
结局指标
主要结局
To compare the quality of recovery at 24 hours post cesarean delivery, measured by the total ObsQoR-11Hindi score, between patients randomized to receive ITM versus those randomized to receive TAP block, within a non-inferiority framework.
时间窗: To compare the quality of recovery at 24 hours post cesarean delivery
次要结局
- Pain intensity with movement (NRS 0-10) (e.g., during transfer/coughing) at 3, 6, 12 and 24 hours post-delivery.(Time to first request for rescue opioid analgesia (in minutes).)
研究者
Dr Abhishek Jadhav
AIIMS New Delhi