Effect of Three Different Postcesarean Analgesic Techniques on ObsQoR-10 Score: Prospective, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- obstetric quality of recovery-10 (ObsQoR-10) scores of parturient at the 24th and 48th postoperative hours
研究概览
简要总结
The aim of this study is to evaluate the effects of three different postsesarean analgesia techniques, including instillation of local anesthetic into the peritoneum with infiltration into all layers of the anterior abdominal wall, intrathecal morphine injection with local anesthetic, and quadrotus lumborum type 1 block, on the postoperative recovery of women using the ObsQoR-10 score..
详细描述
This study will be planned on women who will undergo elective cesarean section surgery with neuraxial anesthesia, after obtaining ethics committee approval and written informed consent from the patients.Parturients will be randomized by the statistician using a computerized random numbers table and divided into 3 equal groups: Group IPLA + LWI, Group QLB 1 and Group M.Postoperatively, patients' ObsQoR-10 scores will be evaluated and recorded at the 24th and 48th hours.
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
- 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
- 否
入选标准
- •Elective cesarean section under spinal anesthesia
- •Full-term singleton pregnancy
- •Agree to participate in the study
- •American Society of Anaesthesiology Score of II
排除标准
- •Contrindication for neuraxial anesthesia
- •ASA≥3, diabetes, preeclampsia, cardiovascular disease, chronic pain and neuropathic pain
- •Age< 18 or > 50
- •Multiple pregnancy
- •Presence of psychiatric diseases
- •Gave a history of allergic to any medication in the study protocol
- •Gave a history of chronic pain
- •Unable to consent
- •BMI>35 kg/m2
- •Those who were given opioids during the operation due to intraoperative pain
- •Those who have had previous abdominal surgery
- •Patients who failed spinal anesthesia and switched to general anesthesia
- •Those who have excessive bleeding or uterine atony during the operation
- •Does not understand VAS
- •Those who have a drain placed in the area to be infiltrated
- •Gave a history of drug addiction
研究组 & 干预措施
Group Intraperitoneal local anasthetic+ loal anesthetic wound infiltration
For Group Intraperitoneal local anasthetic+ loal anesthetic wound infiltration, after the birth of the newborn and placenta, the uterus is taken out and closed, the blood accumulated in the pelvis is carefully wiped with surgical towels, and after complete hemostasis is achieved, sterilely prepared 20 ml 0.5% bupivacaine + 20 ml 2% lidocaine +1 A total of 40 ml of solution containing 200,000 epinephrine will be given to the surgeon. 10 ml of this solution will be instilled into all four quadrants of the uterus before closing the parietal peritoneum or fascia. The parietal peritoneal layer will be sutured or left open, depending on the surgeon's preference. 10 ml will be infiltrated around the edges of the rectus aponeurosis, and the remaining 20 ml will be infiltrated subcutaneously into the wound area.
干预措施: Intraperitoneal local anasthetic application + local anesthetic wound infiltration (Procedure)
Group Morphine
Group Morphine will be given 11.2 mg hyperbaric bupivacaine + 15 µg fentanyl + 150 µg morphine into the spinal space.
干预措施: Intrathecal morphine application (Procedure)
Group Quadratus lumborum block
In Group Quadratus lumborum block, Quadratus lumborum block type I, a total of 40 ml of a solution containing 20 ml of 0.5% bupivacaine + 20 ml of 2% lidocaine + 1:200,000 epinephrine will be applied bilaterally under ultrasound guidance.
干预措施: Quadratus lumborum block tip 1 application (Procedure)
结局指标
主要结局
obstetric quality of recovery-10 (ObsQoR-10) scores of parturient at the 24th and 48th postoperative hours
时间窗: Postoperative 24th and 48th hours
For post-cesarean analgesia, patients will receive instillation of local anesthetic into the peritoneum with infiltration into all layers of the anterior abdominal wall, intrathecal morphine injection with local anesthetic, and quadrotus lumborum type 1 block. ObsQoR-10 scores of the patients will be evaluated at the 24th and 48th hours postoperatively.
次要结局
未报告次要终点
研究者
Aysenur Dostbil
Clinical Professor
Ataturk University