Transversus Abdominis Plane (TAP) Block Versus Intrathecal Morphine for Caesarean Section - Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- cumulative incidence of nausea and/or vomiting at 24 hours
研究概览
简要总结
Analgesia after cesarean section is still not satisfactory for many women. Even if pain reduction is sufficient with the technique of intrathecal morphine injection, side effects such as nausea and pruritus are common.
Since several years, an alternative technique has been studied, the "transversus abdominis plane (TAP)"-block. Here a local anesthetic is injected in the abdominal wall muscles, and this has been shown to give a similar analgesic effect compared to intrathecal morphine, with potentially less side effects.
With this study, we want to evaluate if the TAP-block yields indeed less side effects when compared with intrathecal morphine.
The study will be a prospective study with the patients randomized to either a group with intrathecal morphine or a group with TAP-block.
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)
盲法说明
pharmacy providing identical sets of study drugs and placebo, computerized random sequence generation, sequence held by the pharmacy until study completion
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects must satisfy all of the following criteria to be enrolled into the study:
- •American Society of Anesthesiology (ASA) physical status less than 3 Able to read and understand the information sheet and to sign and date the consent form
- •Scheduled for elective C-section planned with spinal anaesthesia
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •Complicated pregnancy defined as having preeclampsia or placenta accreta, increta and percreta.
- •Drug addiction.
- •Contraindication to spinal anaesthesia (history of clotting disorders, septicemia, local infection at the injection site, spinal malformation, elevated intracranial pressure)
- •Contraindication to TAP block (skin infection, abdominal wall muscle defect such as hernia and previous abdominal wall mesh).
- •BMI>40 kg/m2
- •Weight less than 50 kg the day of the C-section.
- •Height less than 150 cm or more than 175 cm.
- •Allergy/contraindication to any medication used in the study.
- •Previous median abdominal incision. Necessity to perform the C-section urgently before the scheduled date (with less than 24h preparation time).
研究组 & 干预措施
morphine group
spinal anesthesia with intrathecal morphine
干预措施: spinal anesthesia with intrathecal morphine (Other)
TAP group
TAP-block with ropivacaine and clonidine
干预措施: TAP-block with ropivacaine and clonidine (Other)
结局指标
主要结局
cumulative incidence of nausea and/or vomiting at 24 hours
时间窗: 24 hours
Data for this endpoint will be gathered at 6h and 24h postoperatively from nurses' records in the recovery room (at 6h) and on the ward (at 24h), and counterchecked by asking the patient
次要结局
- Cumulative incidence of treated nausea and vomiting at 24h(24h)
- Cumulative morphine consumption at 24 hours(24h)
- Pain score at rest at 6, 24 and 48 hours postoperatively(48h)
- Pain score on movement(48h)
- Maternal satisfaction at 24 and 48 hours postoperatively(48h)
- Cumulative incidence of sedation at 6 and 24h.(24h)
- Cumulative incidence of bradycardia(24h)
- Time until first PCA request(24h)
- Cumulative incidence of pruritus at 24h(24 h)
- Cumulative incidence of arterial hypotension(24h)
- Cumulative incidence of respiratory depression(24h)
- persistent pain at 3 and 6 months postoperatively(6 months)
研究者
Benno Rehberg-Klug
Médecin adjoint agrégé
University Hospital, Geneva