Effect of Adding Dexmedetomidine to Bupivacaine in US- Guided Erector Spinae Plane Block for Post-operative Pain Management in Pediatric Patients Undergoing Lower Abdominal Surgeries
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Duration of Postoperative Analgesia
研究概览
简要总结
This study aims to evaluate the effect of adding dexmedetomidine to bupivacaine in erector spinae plane (ESP) blocks on the duration of postoperative analgesia in pediatric patients undergoing lower abdominal surgery. Effective postoperative pain control in children remains a clinical challenge, and regional anesthesia techniques such as the ESP block have shown promise in improving outcomes.
In this randomized, double-blind clinical trial, pediatric patients scheduled for elective lower abdominal surgeries will be assigned to receive either bupivacaine alone or bupivacaine combined with dexmedetomidine as part of an ultrasound-guided ESP block. The primary outcome is the duration of postoperative analgesia, defined as the time from the block until the first request for rescue analgesia. Secondary outcomes include total analgesic consumption and postoperative pain scores
详细描述
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Preoperative setting:
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A careful history taking will be done from the parents of the child for any medical disorder such as congenital coagulation disorders or therapeutic anticoagulants.
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A complete physical examination of the child will be done, including the central nervous system for signs of mental disturbance, the chest for any deformities or chest infection, the heart for congenital heart disease, and the back for any spinal deformities or infection at the site of injection.
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Routine preoperative investigations will be done to all patients, including laboratory investigations (complete blood picture, liver and kidney function tests, prothrombin time and partial thromboplastin time) and other as needed by the patient condition.
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Written informed consent will be obtained from all participants' parents or legal guardian prior to the study.
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Intraoperative setting:
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All children will be premedicated orally with midazolam (0.05-0.1 mg/kg over 2-3 minutes, maximum 6 mg) 30 minutes prior to surgery. On arrival of the patients to the operative room, routine monitoring with 5-leads electrocardiogram (ECG), non-invasive blood pressure (NIBP) and pulse oximetry will be instituted, then anesthesia will be induced with 8% sevoflurane in 100% oxygen. After an adequate depth of anesthesia is reached, an intravenous access will be placed under aseptic condition, then all patients will receive intravenous (IV) fentanyl (1 µg/kg) and atracurium (0.5 mg/kg), and orotracheal endotracheal intubation will be performed. Anesthesia will be maintained with a mixture of oxygen-air (50% - 50%) and isoflurane
- -1.5%). Muscle relaxation will be sustained during the procedure with incremental doses of IV atracurium (0.1 mg/kg) every 25 minutes.
In group A: US guided ESPB will be performed with aseptic precautions using a (6- 19) MHz linear probe in a sterile cover with sterile jelly (GE LOGIQ 5, USA).
- Technique of US guided ESPB block: The block will be performed by a trained anesthetist in regional anesthetic techniques while the patient in lateral position, the ultrasound transducers will be placed in a parasagittal plane 2-3 cm away from the midline at the level of first lumbar vertebra (L1) (The L1 level will be identified by counting upwards from the sacrum). Sliding the transducer medially till identifying the transverse process which appear as flat acoustic shadow and after identification of erector spinae muscle (ESM) and transverse process, a 22-gauge 50 mm echogenic block needle (Sono Plex® PAJUNK®, Germany) will be introduced in cranio-caudal direction with in-plane technique and after confirming the position of the tip of the needle over the transverse process with negative aspiration to blood or air, Bupivacaine 0.25% (with a maximum dose 2 mg/kg) plus Dexmedetomidine (0.5µg/kg), putting into consideration that the total volume to be 0.3 ml/kg on each side, will be injected. The spread of local anesthetic in a plane below the erector spinae muscle will be visualized.
- The skin incision will be made 15 min after the block.
- Baseline values of heart rate (HR) and mean blood pressure (MAP) will be recorded before skin incision and then recorded at 5, 30, 60 minutes after skin incision and at the end of surgery. Also, patients will be monitored for sign of local anesthetic toxicity.
- Any complications related to the block given will be recorded including hematoma, intravascular injection, and allergic reactions.
- If local anesthetic toxicity occurred, cardiovascular and respiratory support and 20% intralipid bolus of 1.5 ml/kg over 2-3 min will be given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Year 至 7 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric patients aging 1-7 years old of both sexes.
- •Patients scheduled for unilateral or bilateral lower abdominal surgeries.
- •American Society of Anesthesiologists (ASA) Physical Status Class I, II
排除标准
- •Parents or legal guardian refusal of participation in the study.
- •Contraindication to regional anesthesia (including coagulopathy and local infection).
- •History or known allergy to local anesthetics.
- •Past history of any complications related to the block. (including hematoma and intravascular injection)
- •Spinal anomalies altered mental status, a history of developmental delay.
- •Additional surgical procedures at different surgical sites.
研究组 & 干预措施
Bupivacaine Group
Patients in this group will receive an ultrasound-guided erector spinae plane (ESP) block with bupivacaine only.
干预措施: Bupivacaine (Drug)
Bupivacaine + Dexmedetomidine Group
Patients in this group will receive an ultrasound-guided erector spinae plane (ESP) block with a combination of bupivacaine and dexmedetomidine.
干预措施: Bupivacaine (Drug)
Bupivacaine + Dexmedetomidine Group
Patients in this group will receive an ultrasound-guided erector spinae plane (ESP) block with a combination of bupivacaine and dexmedetomidine.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Duration of Postoperative Analgesia
时间窗: Up to 24 hours after surgery
Measurement of the time from recovery of anesthesia to the need of first given dose of rescue analgesia.
次要结局
- Total Postoperative Analgesic Consumption(Within 24 hours postoperatively)
- Postoperative Pain Scores(At 1, 2, 4, 6, 12, and 24 hours after surgery)
- Total intraoperative analgesics(During the operation from the induction of anesthesia until the recovery.)
- Incidence of Adverse Effects(Within 24 hours postoperatively)
