Quadratus Lumborum Block Type 2 Versus Wound Infiltration in Cesarean Section: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Total amount of piritramide used in first 24 hours
研究概览
简要总结
Effective postoperative analgesia after cesarean section (CS) is important because it enables early ambulation and facilitates breast-feeding. A 2009 Cochrane review concluded that wound infiltration with local analgesic after CS reduced opioid consumption. In addition, two regional anesthetic techniques, the transversus abdominis plane (TAP) block and the quadratus lumborum block (QLB), have been shown in multiple studies to reduce post-operative opioid consumption after CS. A recent randomized controlled trial showed that QLB is more effective in reducing morphine consumption post-CS compared to TAP. No randomized controlled trial to date, however, compared the analgesic effect of QLB with infiltration of the wound after CS. The objective of the study is to compare the analgesic effect of QLB type 2 with wound infiltration after CS.
详细描述
Effective postoperative analgesia after cesarean section (CS) is important because it enables early ambulation and facilitates breast-feeding. Post-CS analgesia is usually multimodal. At our hospital, patients are routinely given a combination of parenteral paracetamol, metamizole and tramadol at fixed intervals with additional intravenous piritramide on demand. The well-known side effects of piritramide (nausea, vomiting, and sedation) may interfere with interaction between mother and child, breast-feeding and post-partum experience in a dose-dependent manner. Alternative strategies to reduce rescue opioid analgesic consumption post-CS section are, therefore, required.
A 2009 Cochrane review concluded that wound infiltration with local analgesic after CS reduced opioid consumption. In addition, two regional anesthetic techniques, the transversus abdominis plane (TAP) block and the quadratus lumborum block (QLB), have been shown in multiple studies to reduce post-operative opioid consumption after CS. A recent randomized controlled trial showed that QLB is more effective in reducing morphine consumption post-CS compared to TAP.
Telnes et al. compared TAP block with wound infiltration with local anesthetic following CS. They found no reduction in cumulative morphine consumption and more pronounced sedation associated with TAP block. No randomized controlled trial to date, however, compared the analgesic effect of QLB with infiltration of the wound after CS.
The objective of the study is to compare the analgesic effect of QLB type 2 with wound infiltration after CS.
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
Randomization will be performed in a 1:1 ratio using a computer generated randomization sequence. A sealed opaque envelope containing the study number will opened by an anesthetist nurse who will not be involved in the study. This anesthetist nurse will prepare the study medication and label the syringes with a unique study number which will be used to identify the study medication and will be revealed only on completion of data collection at the end of the study. The anesthetists, obstetricians, nurses who will be involved in the study, parturients, and other healthcare providers who will be involved in postoperative care will be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Parturients scheduled for an elective caesarean delivery under spinal anaesthesia with an American Society of Anesthesiologists physical status I or II, singleton pregnancy, and gestational age ≥ 37 completed weeks.
排除标准
- •Congenital or acquired coagulopathy.
- •Allergy to local anaesthetics.
- •History of drug abuse.
研究组 & 干预措施
Quadratus Lumborum Block type 2
The obstetrician (multiple, experienced clinicians) will infiltrate the wound (Pfannenstiel incision) subcutaneously at the end of surgery with 20 ml normal saline. Subsequently, a US-guided QLB using a linear/convex transducer will be performed by the anesthesiologist using 30 ml levobupivacaine 0.18% (20 ml 0.25% levobupivacaine + 10 ml normal saline) bilaterally (60 ml in total).
干预措施: Quadratus Lumborum Block type 2 (Drug)
Wound Infiltration
Patricipants will receive 20 ml levobupivacaine 0.25% infiltration in the surgical wound and US-guided QLB with 30 ml normal saline bilaterally (60 ml in total).
干预措施: Wound Infiltration (Drug)
结局指标
主要结局
Total amount of piritramide used in first 24 hours
时间窗: 24 hours post CS
Total amount of piritramide administered in the first 24 hours after CS
次要结局
- Numerical rating scale (0-10) at rest(Within 48 hours post CS)
- Nausea(within 24 hours post CS)
- Total amount of piritramide used in first 48 hours(48 hours post CS)
- Numerical rating scale (0-10) with movement(Within 48 hours post CS)
- Surgery-to-first-ambulation time(within 48 hours post CS)
- Surgery-to-breast-feeding time(within 48 hours post CS)
- Ramsay scale(within 24 hours post CS)
- Itching(within 24 hours post CS)
研究者
Miha Lucovnik
assistant professor
University Medical Centre Ljubljana