Ultrasound-guided Transversus Abdominis Plane Block Versus Local Wound Infiltration for Postoperative Analgesia After Cesarean Delivery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To compare cumulative consumption of opioids in the first 24 hours after cesarean section
研究概览
简要总结
The goal of this clinical trial is to learn if transversus abdominis plane (TAP) block will reduce the cumulative opioid consumption compared to local wound infiltration (WI). It will also learn about the pain scores compared between TAP and WI groups. The main questions it aims to answer are:
Has the pain score after cesarean section been less in TAP compared to WI group? Has the cumulative consumption of opioids reduced in TAP as compared to WI group? Researchers will compare TAP group with WI group based on postoperative pain score and opioid used.
Participants will:
Be given intervention either TAP or WI during the cesarean section. Pain score will be recorded during the postoperative period at PACU, 6, 12 and 24 hours after cesarean section.
The postoperative pain will be rescued with opioid, and the cumulative use of opioids will be recorded.
详细描述
Study title:
Ultrasound-guided Transversus abdominis plane block versus local wound infiltration for postoperative analgesia after cesarean delivery: A randomized controlled trial
Study setting:
Bhutan is a small, landlocked country in the Himalayas, sandwiched between China and India. Its total population is over 0.7 million. 20 Healthcare in Bhutan is publicly owned and solely state-funded. It has a three-tiered health system with the primary health centers at the lowest level followed by district hospitals, regional referral hospitals, and the national referral hospital. 21 Jigme Dorji Wangchuk (JDW) National Referral Hospital is a tertiary referral hospital and a teaching hospital located in the capital city, Thimphu. The Department of Anesthesiology at JDW National Referral Hospital administers anesthesia in eight operation rooms. The department has nine anesthesiologists, eleven nurse anesthetists, seventeen anesthesia technicians, and five residents. The department also has pre-operative and post-anesthesia care unit (PACU) nurses.
In the pre-operative room, pregnant mothers posted for CS are received by the nurses, who complete preoperative documentation and administer prophylactic antibiotics. CS is performed by the resident under the supervision of a consultant or by a consultant obstetrician following a standard procedure under spinal anesthesia. Usually heavy bupivacaine ....mg (2.5ml) with fentanyl ...mg (ml) is administered.
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
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All elective cesarean sections performed under spinal anesthesia,
- •American Society of Anesthesiologists physical status classification II (ASA II).
排除标准
- •Those mothers underwent emergency cesarean section
- •Contraindication to spinal anesthesia (increased intracranial pressure, coagulopathy, or local skin infection)
- •hypersensitivity to any of the drugs used in the study
- •Failed spinal anesthesia converted to general anesthesia
- •Pre-existing pain syndromes
- •History of recent opioid exposure
- •Significant cardiovascular, renal, or hepatic disease,
- •Fetal abnormalities or negative fetal outcomes were excluded from the study
结局指标
主要结局
To compare cumulative consumption of opioids in the first 24 hours after cesarean section
时间窗: within 24 hours postoperative period
Cumulative use of Inj. morphine during the postoperative period was significantly less in the TAP group than in the WI group (5.4 ± 0.9 Vs 6.1 ± 0.6, p=0.017)
次要结局
- To compare the pain score using the Visual Analogue Scale between the intervention (TAP) and comparator (WI) group(within 6, 12 and 24 hours postoperative period)
- To compare the postoperative complications between the intervention (TAP) group with the comparator (WI) group.(Within first 24 hours postoperative period)