Efficacy of Neostigmine as an Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block as a Postoperative Analgesia After Caesarean Delivery.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- The time of the first postoperative analgesic requirement
研究概览
简要总结
Cesarean birth is a common surgical procedure. After cesarean birth, postsurgical pain may delay recovery, interfere with maternal-newborn bonding, and reduce the breastfeeding if not adequately controlled. Postpartum analgesia has become a common concern.
Many adjuvant drugs used for peripheral nerve blocks as( N-methyl-d-aspartate (NMDA) receptor antagonists , Magnesium , Ephedrine , Dexamesathone , Fentanyl , Midazolam and Neostigmine) The potential of neostigmine as an adjuvant in peripheral nerve block is through its action to increase acetylcholine at muscarinic junctions of peripheral nerves. 500 mcg neostigmine was used as adjuvant to local anesthetic in an axillary brachial plexus block leads to decreased pain and less use of analgesics in the first 24 hours postoperatively with no incidence of adverse effects.
详细描述
This prospective double-blinded randomized controlled study will be done on parturients that are scheduled for elective cesarean delivery under spinal anesthesia to assess the efficacy of neostigmine as an adjuvant to isobaric bupivacaine inTranversus abdominis plane (TAPB) for postoperative analgesia in cesarean section under spinal anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
The injectate used for TAPB will be prepared according to the group by an anesthesiologist who won't be involved in the data collection
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age from 19 to 40 years old
- •American Society of Anesthesiologists (ASA) physical status II patients
- •Singleton pregnancies with a gestational age of at least 37 weeks.
- •Patients undergoing spinal anesthesia for cesarean delivery via a Pfannenstiel incision with exteriorization of the uterus.
排除标准
- •Age < 19 or > 40 years.
- •Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m
- •Inability to comprehend or participate in the pain scoring system.
- •Contraindications to spinal anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
- •Hypersensitivity to any drug used in the study.
- •Any hypertensive disorders of pregnancy.
- •Renal impairment or other contraindications to non-steroidal anti-infilamatory drugs (NSAIDS).
- •Significant cardiovascular, renal or hepatic abnormalities.
- •Patients with history of opioid intake, drug abusers or psychiatric patients
研究组 & 干预措施
Bupivacaine group (Group-B)
After cession section, patients Will receive ultrasound (US)-guided bilateral TAP block with 20 mL bupivacaine 0.25% plus 1 mL of normal saline (Total volume of 21mL in each side
干预措施: Bupivacaine (Drug)
Bupivacaine-Neostigmine group (Group-BN)
After cession section, patients Will receive ultrasound (US)-guided bilateral TAP block with 20 mL bupivacaine 0.25% plus 1 mL of 500 mcg neostigmine (Total volume of 21mL in each side
干预措施: Bupivacaine-Neostigmine (Drug)
结局指标
主要结局
The time of the first postoperative analgesic requirement
时间窗: during the first 24 postoperative hours
during the first 24 postoperative hours
次要结局
- Mean arterial blood pressure (MBP)(basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours)
- The visual analog scale (VAS) scores during movement(during the first 24 postoperative hours)
- Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the(during the first 24 postoperative hours)
- The visual analog scale (VAS) scores during rest(during the first 24 postoperative hours)
- heart rate (HR)(basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours)
- the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome(during the first 24 postoperative hours)
- The side effects (nausea, vomiting, abdominal colic and lower limb weakness)(during the first 24 postoperative hours)
- Patient satisfaction about the quality of postoperative analgesia(during the first 24 postoperative hours)
研究者
maha abou-zeid
Assistant Professor of Anesthesia and Surgical Intensive Care
Mansoura University