Randomised Controlled Clinical Trial Analgesic Effect of Bupivacaine Plus Ketamine Versus Bupivacaine Alone in Transversalis Fascia Plane Block After Cesarean Section Under Spinal Anaesthesia
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- The mean VAS pain on movement will be recorded as the primary outcome of the study
研究概览
简要总结
The objective of this study is to compare the efficacy of transversalis fascia plane block using bupivacaine and ketamine versus bupivacaine alone for pain management after cesarean section under spinal anaesthesia.
详细描述
Cesarean section (CS) is one of the most common surgeries and usually causes moderate to severe pain for up to 48 h. The rate of CS, which is a life-saving surgical procedure in cases of certain complications that occur during pregnancy and birth, has exceeded 20% worldwide Pain control after CS has crucial importance, especially in the first 24 h, to facilitate early ambulation and the establishment of breastfeeding. Insufficient analgesia in the postoperative period may cause a number of undesirable effects, such as patient discomfort, thromboembolism due to extended immobilization, and increased pulmonary secretions resulting in complications The well-known side effects of analgesic morphine as nausea, vomiting, itching and sedation, may interfere with the interaction between mother and child, breastfeeding and post-partum experience in a dose-dependent manner. However, a number of alternative strategies have been described in order to reduce morphine consumption post-operatively .
The mode and type of analgesia should be safe and effective. A stimulus caused by a lesion in tissue or organs during surgery is the cause of postoperative pain .
The primary source of pain after abdominal surgeries, including CS, are the anterior abdominal wall and abdominal viscera, and blocking these areas could provide proper postoperative analgesia .
Recently, the application of fascial plane blocks has increased due to the widespread use of ultrasound among anesthesiologists and the avoidance of opioids in a multimodal analgesic strategy. Different regional anesthetic techniques have been introduced, including ilioinguinal nerve blocks, abdominal field blocks, Transversalis Fascia Plane (TFP) blocks, and Transversus Abdominis Plane (TAP) blocks to alleviate pain from the abdominal wall incision .
Transversalis Fascia Plane, performed in the posterior axillary line, blocks branches of L1 nerve roots, including ilioinguinal and iliohypogastric nerves. This method has been used to control postoperative pain in patients undergoing different lower abdominal surgeries A variety of anesthetic agents such as bupivacaine, levobupivacaine, and ropivacaine are commonly used in TAP blocks. These drugs provide short-term analgesia and primarily alleviate somatic pain. To extend the duration of analgesic efficacy, various adjuvants such as opioids, ketamine, clonidine, and alpha-2 agonists like dexmedetomidine have been added .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients aging ≥ 21 years to ≤
- •Patients undergoing cesarean section under spinal anesthesia.
- •American Society of Anesthesiologists (ASA) physical statusphysical status classes II.
排除标准
- •Patient's refusal of procedure or participation in the study.
- •Coagulopathy and bleeding disorders.
- •Use of chronic pain medications.
- •Pregnancy-induced hypertension or diabetes.
- •Evidence of Local skin infections at site of injection.
- •Body mass index >40kg/m2
- •A history of relevant local anesthetic allergy.
研究组 & 干预措施
Ketamine and bupivacaine
Transversalis fascia plane block
干预措施: Ketamine (Drug)
Ketamine and bupivacaine
Transversalis fascia plane block
干预措施: Bupivacain (Drug)
Bupivacaine alone
Transversalis fascia plane block
干预措施: Bupivacaine (Drug)
结局指标
主要结局
The mean VAS pain on movement will be recorded as the primary outcome of the study
时间窗: day 1
Pain intensity will be assessed using the Visual Analog Scale (VAS), where 0 = no pain and 10 = worst pain. Patients will report their pain levels at rest and during movement at 24 hours after the transversalis fascia plane block. The mean VAS score will be compared between the ketamine + bupivacaine group and the bupivacaine-only group.
次要结局
- Time to first rescue analgesia will be recorded(Day 1)
- total requirements of rescue analgesia Nalbuphine over the first 24 hours postoperative will be recorded(Day 1)
