TAP Block Versus ESP Block in Patients Undergoing Elective Cesarean Section: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain at Rest at 6 hours
研究概览
简要总结
This study is comparing two types of pain relief techniques-TAP block and ESP block-for women having an elective cesarean section. Both techniques involve injecting local anesthetic under ultrasound guidance to numb nerves and reduce pain after surgery. The TAP block mainly relieves pain in the abdominal wall, while the ESP block may reduce both abdominal wall and deeper, organ-related pain. The main goal is to see if there's a difference in pain at rest six hours after surgery. The study will also look at pain at later time points, the amount of opioid medication needed, how quickly women can walk, and when they start breastfeeding.
A total of 156 women will be randomly assigned to receive one of the two blocks after standard spinal anesthesia. Pain will be measured using a simple 0-10 scale at 6, 12, and 24 hours, both at rest and during movement. The study follows strict ethical rules, ensures patient privacy, and all results-whether positive or negative-will be shared to help improve pain management after cesarean delivery.
详细描述
This study is a prospective, monocentric, randomized controlled trial designed to compare the analgesic efficacy of the transversus abdominis plane (TAP) block versus the erector spinae plane (ESP) block in women undergoing elective cesarean section. Cesarean delivery, one of the most commonly performed surgical procedures worldwide, is associated with both somatic and visceral postoperative pain. Optimizing pain control is critical not only for maternal comfort but also for reducing complications, facilitating early mobilization, and supporting breastfeeding and maternal-infant bonding. While the TAP block provides effective somatic analgesia of the abdominal wall with a rapid learning curve, it does not address visceral pain. Conversely, the ESP block offers multidermatomal coverage, potentially reducing both somatic and visceral components of postoperative pain and opioid consumption. The primary objective of the study is to evaluate postoperative pain at rest six hours after surgery, with secondary outcomes including pain at various time points, opioid consumption, time to first rescue analgesia, ambulation, and initiation of breastfeeding.
A total of 156 patients meeting inclusion criteria (age 18-45 years, elective cesarean, informed consent) will be randomized to receive either a bilateral TAP or ESP block following standardized spinal anesthesia. Pain scores will be assessed using an 11-point Numeric Rating Scale (NRS) at 6, 12, and 24 hours postoperatively, both at rest and with movement. Opioid use, time to ambulation, and breastfeeding initiation will also be recorded. The study is powered to detect a clinically significant difference in pain scores, and data analysis will include tests for normality, parametric and non-parametric comparisons, repeated-measures analysis, regression models, and survival analysis for time-to-event outcomes. The trial adheres to ethical standards, including informed consent and data privacy, and the results will be disseminated regardless of outcome, contributing to evidence-based practice in post-cesarean analgesia.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Outcome assessor and investigator will be blind of the procedure as each patient will be associated with an unique ID.
Patients and patient care provider could not be blind given the nature of the procedure
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
- •Age between 18 and 45 years
- •Elective cesarean section
- •Ability to provide informed consent
排除标准
- •Allergy to any of the drugs used in the study
- •Heart disease with impaired cardiac function
- •Stage III or higher kidney failure
- •Coagulation disorders (platelets <100,000/μL or INR >1.5) or severe liver disease
- •Degenerative central nervous system diseases or peripheral neuropathies
- •Previous uterine surgery (e.g., myomectomy)
- •Previous cesarean section
- •Pre-pregnancy weight <55 kg
研究组 & 干预措施
ESP block
Patients will undergo preoperative bilateral ESP block with ropivacaine 0.375% 20 mL per side (total 40 mL)
干预措施: ESP block (Procedure)
TAP block
Patients will undergo preoperative bilateral TAP block with ropivacaine 0.375% 20 mL per side (total 40 mL)
干预措施: TAP block (Procedure)
结局指标
主要结局
Pain at Rest at 6 hours
时间窗: 6 hours after end of surgery
Pain measured at Rest with Numeric Rating Scale (minimun 0- maximum 10) with 0 meaning no pain and 10 high pain
次要结局
- Pain at Rest at 12 hours(12 hours after end of surgery)
- Pain at Rest at 24 hours(24 hours after end of surgery)
- Pain at Movement at 6 hours(6 hours after end of surgery)
- Pain at Movement at 12 hours(12 hours after end of surgery)
- Pain at Movement at 24 hours(24 hours after end of surgery)
- Milligram of Morphine equivalents in the first 24 postoperative hours(from the end of the surgery to 24 hours after the surgery)
- Time to rescue analgesic requirement(Form the end of the surgery to the first rescue analgesic requirement (up to o 24 hours after the surgery))
- Time to breast feeding(Form the end of the surgery to the start of breast feeding (up to o 24 hours after the surgery))
- Time to deambulate(Form the end of the surgery to the start of deambulation (up to o 24 hours after the surgery))
研究者
Alessandro De Cassai
Principal Investigator
University of Padova