Determination of the Efficay of the Transversus Abdominis Plane (TAP) Block as Part of a Multimodal Regimen for Post-cesarean Delivery Analgesia: a Double Blinded Placebo-controlled Study.
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
- 1
- 主要终点
- Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively.
研究概览
简要总结
The purpose of this study is to determine if patients having the transversus abdominal place (TAP) block at the end of a cesarean delivery have less pain in the post-delivery period than those who do not. Freezing medication is injected between the layers of muscle on either side of the belly, to freeze the nerves that carry pain stimuli from an abdominal wound. This technique has been useful for many abdominal operations, and has recently been studied in cesarean sections, however more information is needed.
详细描述
A cesarean section is a surgical procedure and, like all surgeries, there is pain after the operation. The purpose of this study is to find out if patients have less pain after a cesarean delivery when they receive an injection of local anesthetic on either side of their abdomen, into the plane of the transversus abdominis muscle. We are also interested in whether or not this injection decreases the need for other pain-killing medication during this time.
Patients will randomly be assigned to receive either local anesthetic or a placebo. In addition, all patients will receive the usual standard of care and medication for pain. At 6, 12, 24 and 48 hours after the operation, patients will be asked about their pain and satisfaction with pain management. The risk of side effects is very low, as the block is done in an area with low blood supply. We propose that the addition of the TAP block to the current multi-modal regimen of post-cesarean pain management will reduce pain scores and requests for additional analgesia post-operatively, as well as increase patient satisfaction with their pain control.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing elective cesarean delivery
排除标准
- •Patients unable to communicate in English
- •Patients with an American Society of Anesthesiologists (ASA) classification of 3 or higher
- •Patients with contraindications to spinal anesthesia
- •Patients with an allergy to ropivacaine, morphine, ketorolac or acetaminophen
- •Patients who have taken any pain medication in the past 24 hours
- •Patients with a BMI > 40
研究组 & 干预措施
1
Ropivacaine
干预措施: ropivacaine (Drug)
2
Placebo
干预措施: saline solution (Drug)
结局指标
主要结局
Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively.
时间窗: 24 hours
次要结局
- Presence of pain 6 weeks postoperatively.(6 weeks)
- Pain at rest and on movement by VAS at 6, 12, 24 & 48 hours postoperatively.(48 hours)
- Opioid consumption at 6, 12, 24 & 48 hours postoperatively.(48 hours)
- Time to first maternal request for supplemental analgesia.(48 hours)
- Maternal satisfaction with pain management on a scale of 0-10, at 6, 12, 24 and 48 hours postoperatively.(48 hours)