Dexmedetomidine vs Ketamine as Adjuvants to Bupivacaine in Transversus Abdominus Plane Block in Inguinal Hernioplasty: A Randomized Clincal Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Numeric Pain Rating Scale
研究概览
简要总结
This clinical trial aims to compare the effect of adding dexmedetomidine versus ketamine to bupivacaine in transversus abdominis plane block in patients undergoing unilateral inguinal hernioplasty. The key questions it is expected to answer are:
To what extent do dexmedetomidine and ketamine adjuvants, when combined with bupivacaine, offer a longer analgesic period in a Transversus Abdominis Plane (TAP) block?
To investigate the pain at rest and coughing with particular time intervals (0, 2, 4, 6, and 12 hours) after the operation.
researchers will rely on three groups:
Group A (Dexmedetomidine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine + 1 mcg/kg dexmedetomidine + normal saline.
Group B (ketamine group): patients will receive 20 ml of solution containing 1 mg/kg bupivacaine + 0.5 mg/kg ketamine + normal saline.
Group C (Control Group): Patients will receive 20 ml of solution containing 1 mg/kg bupivacaine + normal saline.
Participants will:
have general anesthesia in their planned unilateral hernioplasty. have an ipsilateral US guided TAP block (posterior approach) using one of the three study solutions at the end of the surgery prior to be waked up.
Measure their Numeric Pain Rating Scale (NRS) at rest and coughing at particular time intervals (0, 2, 4, 6, and 12 hours) after the operation.
详细描述
Preoperative Assessment:
Patients scheduled for unilateral inguinal hernioplasty will be assessed preoperatively by evaluating their medical history, laboratory investigations, and fulfillment of the above inclusion criteria. The patient's preparation will be done by IV cannulation with an 18G cannula, and infusion of 500 ml of Ringer's solution will be started, and about 20 minutes before anesthesia induction, midazolam (0.05 mg/kg) will be received as a sedative premedication.
Intraoperative Procedures and Assessments:
After reaching the operating room, standard monitoring will be applied, which includes electrocardiography (ECG), non-invasive blood pressure, and pulse oximetry for peripheral oxygen saturation (SPO2). After preoxygenation, induction of general anesthesia will be done by IV injection of propofol (2 mg/kg), fentanyl (2 mcg/kg), atracurium (0.5 mg/kg), and inhalational isoflurane 1.2%, followed by endotracheal intubation and controlled mechanical ventilation with tidal volume 7-8 ml/kg, respiratory rate 12/min, and FIO₂ 100%. Then anesthesia will be maintained by inhalational isoflurane, atracurium 0.1 mg/kg every 20 minutes, and intraoperative fluid (Ringer's solution), which was calculated to cover the maintenance, deficit, and 3rd space requirement.
At the end of surgery an ipsilateral US-guided TAP block will be given to all the patients by placing a linear US probe (high-frequency probe 10-12 MHz) connected to a portable US unit initially in the mid-axillary plane midway between the lower costal margin and the highest point of iliac crest, then it was moved posteriorly till a scan reveals the transversus abdominis muscle tailing off into the aponeurosis, near the Quadratus lumborum muscle. The injection site was superficial to the aponeurosis near quadratus lumborum. while the patient in supine position with slight lateralization After skin disinfection, a 22-G needle with an injection line will be inserted in plane with the probe. Once the tip of the needle is placed in place, and after negative suction, 5 ml of 0.9% saline will be injected to verify the right place, then one of the three study solutions will be injected.
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, Care Provider, Investigator)
盲法说明
Sampling Method: Simple random sample. Randomization: Computer generated random list. Blinding: The patient, the physician performing the block and the investigator will be blinded as regard tools and patient's group.
Concealment: Randomization list will be concealed from all members off the study, known only by one person which is not included in it.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing unilateral inguinal hernioplasty of ASA I or II.
- •Age group: 18-60 years old.
排除标准
- •Patient refusal.
- •known allergy to any of the used drugs
- •ASA III or above
- •Coagulation disorders and thrombocytopenia
- •Body mass index (BMI) >30
- •Infection at needle insertion site
- •Patients undergoing bilateral inguinal hernioplasty
研究组 & 干预措施
DEX on TAP
Group A (Dexmedetomidine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine + 1mcg/kg dexmedetomidine +normal saline.
干预措施: Dexmedetomidine & Bupivacaine. (Drug)
KET on TAP
Group B (ketamine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine+0.5 mg/kg ketamine + normal saline.
干预措施: ketamine and bupivacaine injection (Drug)
TAP
Group C (Control Group): Patients will receive 20 ml solution containing 1 mg/kg bupivacaine + normal saline.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Change in Numeric Pain Rating Scale
时间窗: Immediately postoperative - 2 hours postoperatively - 4 hours postoperatively - 6 hours postoperatively - 12 hours postoperatively
The Numeric Pain Rating Scale (NRS) is an effective method for measuring pain intensity. It consists of an 11-point scale where: 0 represents no pain - 10 represents the worst pain imaginable. Patients are asked to select a whole number that best reflects their pain intensity or average pain level.
次要结局
- Change in Mean arterial blood pressure(Immediately postoperative - 2 hours postoperative - 4 hours postoperative)
研究者
Mariam Mikhail Fouad Hanna
Assistant Lecturer at Department: Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University.
Ain Shams University