Comparison of the Application of Lidocaine With Intraperitoneal Bupivacaine in Cesarian Operations Wound Infiltration: Randomized, Double-blind, Placebo Controlled Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Visual Analog Scale
研究概览
简要总结
Postoperative pain control is important to reduce morbidity and mortality, and this becomes even more important after cesarean delivery. Severe postpartum pain is associated with chronic pain, and the mother faces a 2.5-fold increased risk of chronic pain and a 3-fold increased risk of postpartum depression compared to mild ones Postoperative pain management is more difficult in the postpartum period. Because the main analgesics used are opioids that are excreted from milk and the newborn may be exposed to the side effects of these drugs . Therefore, multimodal approach is recommended in pain management.
Surgical wound infiltration (LWI) of local anesthetics is an important component of multimodal analgesia . Some of the pain from surgery is caused by an inflammatory response to the surgical incision; therefore, reducing this inflammation can provide a better analgesia and also minimize side effects .
Ease of use and safety of intraperitoneal local anesthetics (IPLA) has been demonstrated in studies and has become a useful alternative to opioid-based analgesic regimens for the treatment of acute postoperative pain.
Investigators aim is to compare the effectiveness of LWI and IPLA applications on postoperative analgesia in women undergoing elective cesarean delivery under spinal anesthesia (SA).
Investigators hypothesis, H0, was that there was no statistically significant difference between the three groups in the mean postoperative pain scores at the 24th hour during movement.
H1 was a statistically significant difference between the mean postoperative pain scores at the 24th hour during the movement between the three groups.
The primary aim of the study was pain scores during the postoperative 24th hour mobilization.
Secondary outcome was total fentanyl consumption (µg) in the first postoperative 24 hours
详细描述
COMPARISON OF THE APPLICATION OF LIDOCAINE WITH INTRAPERITONEAL BUPIVACAINE IN CESARIAN OPERATIONS WOUND INFILTRATION: RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY.
INTRODUCTION The most common surgical procedure in pregnant women is cesarean . Postoperative pain control is important to reduce morbidity and mortality, and this becomes even more important after cesarean delivery. A mother with pain has trouble feeding the newborn . In addition, severe postpartum pain is associated with chronic pain, and the mother faces a 2.5-fold increased risk of chronic pain and a 3-fold increased risk of postpartum depression compared to mild ones .
One of the most important features of a good anesthesia application is a good postoperative pain management. This management is more difficult in the postpartum period. Because the main analgesics used are opioids that are excreted from milk and the newborn may be exposed to the side effects of these drugs . Therefore, multimodal approach is recommended in pain management. In multimodal analgesia, the drugs interact with each other and show a synergistic and additive effect, thus providing better pain control with fewer side effects .
Neuraxial blocks, peripheral nerve blocks, NSAIDS and local anesthetic infiltration of the wound, intraperitoneal local anesthetic delivery were used as part of the multimodal approach.
Surgical wound infiltration (LWI) of local anesthetics is an important component of multimodal analgesia . Some of the pain from surgery is caused by an inflammatory response to the surgical incision; therefore, reducing this inflammation can provide a better analgesia and also minimize side effects .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, 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
- •Pregnant women
- •18-50 years
- •ASA I-II,
- •≥34th gestational week
排除标准
- •Patients with neuraxial anesthesia contraindications
- •Patients allergic to drugs to be used in the study
- •BMI> 35 kg / m2
- •Diabetes, preeclampsia, cardiovascular disease, chronic pain and neuropathic pain
- •Patients who have been given opioids in operation due to intraoperative pain
- •Patients with unsuccessful spinal anesthesia who underwent general anesthesia
- •Patients with excessive bleeding during the operation, uterine atony, placement of the drain in the area to be infiltrated
- •Patients who do not want spinal anesthesia,
- •Cannot understand VAS
- •History of drug addiction and psychiatric illness
研究组 & 干预措施
IPLA:intraperitoneal local anesthetic
intraperitoneal local anesthetic:after the birth of the newborn and placenta, the uterus is closed and the blood accumulated in the pelvis is carefully wiped with surgical towels, after hemostasis is fully achieved, a total of 20 ml solution containing 10 cc of 0.5% bupivacaine +10 cc 2% lidocaine and 2 injectors containing 20ml saline and the 20ml solution were given to the surgeon. The 20 ml solution containing bupivacaine and lidocaine was injected into the uterine peritoneal region by spraying 5 mL to each quadrant of the uterus before closing the parietal peritoneum or fascia. The parietal peritoneal layer was sutured or left open at the surgeon's preference. At the end of the operation, 20 ml of saline solution was applied subcutaneously in the form of LWI instead of the incision before the skin was closed.
干预措施: Intraperİtoneal local anaesthesİc İn cesarean sectİon (Other)
LWI:Surgical wound infiltration
Surgical wound infiltration:a solution containing 20 ml of saline was added to all four quadrants of the uterus in 5 ml volume and 20 ml solution containing lidocaine and bupivacaine were subcutaneously in the form of LWI before the skin was closed.
干预措施: Local wound infiltrasyon (Other)
C: CONTROL GROUP
one of the two sterile injectors containing 20 ml of saline was applied to the uterine peritoneal region and the other was applied to the incision area as a local subcutaneous wound infiltration.
干预措施: Control group (Other)
结局指标
主要结局
Visual Analog Scale
时间窗: 24th hours
The primary outcome in this study is visual analog scores (VAS scores 0 to 10) during mobilization postoperative 24th hour. Higher scores mean a worse outcome.
次要结局
- patient satisfaction(24th hours)
研究者
Aysenur Dostbil
Principal Investigator
Ataturk University