Ultrasound-Guided Ilioinguinal-Iliohypogastric Nerve Block Following Spinal Anesthesia Comparing Dexmedetomidine Versus Nalbuphine as Adjuvants to Bupivacaine in Unilateral Inguinal Hernia Repair: A Prospective, Randomized, Double-Blind Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 102
- 主要终点
- Time to First Rescue Analgesia
研究概览
简要总结
This study evaluates and compares the pain-relieving efficacy and safety of adding either dexmedetomidine or nalbuphine to bupivacaine in an ultrasound-guided ilioinguinal-iliohypogastric nerve block for patients undergoing elective unilateral inguinal hernia repair under spinal anesthesia.
While spinal anesthesia provides effective surgical anesthesia, postoperative pain often increases as the block recedes. Supplementing spinal anesthesia with an ultrasound-guided peripheral nerve block targeting the ilioinguinal and iliohypogastric nerves provides localized pain relief. Adding adjuvant medications to the local anesthetic may extend the duration of pain control and reduce systemic analgesic requirements.
Participants are randomly allocated to one of three groups:
- Control Group: Receives bupivacaine with normal saline.
- Nalbuphine Group: Receives bupivacaine combined with nalbuphine.
- Dexmedetomidine Group: Receives bupivacaine combined with dexmedetomidine.
The primary objective is to assess the duration of analgesia by measuring the time from the regression of spinal sensory anesthesia until the first request for rescue pain medication. Secondary objectives include evaluating total 24-hour pain medication consumption, postoperative pain scores, vital signs, sedation scores, patient satisfaction, and side effects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 years
- •American Society of Anesthesiologists (ASA) physical status I or II
- •Scheduled for elective unilateral primary inguinal hernia repair under spinal anesthesia supplemented with ilioinguinal-iliohypogastric nerve block
- •Body weight between 45 and 100 kg and body mass index (BMI) <= 35 kg/m^2
- •Ability to understand the study protocol, comply with study requirements, and communicate pain intensity using the Visual Analog Scale (VAS)
排除标准
- •Known allergy or hypersensitivity to amide-type local anesthetics, dexmedetomidine, or nalbuphine
- •Contraindications to spinal anesthesia (e.g., severe hypovolemia, elevated intracranial pressure, active infection at the lumbar puncture site, severe spinal deformity)
- •History of neurological disorders (e.g., peripheral neuropathy, myopathy, seizure disorders, or cognitive impairment)
- •Coagulopathy, concurrent anticoagulant therapy, or local infection at the block site contraindicating regional anesthesia
- •Severe hepatic, renal, or cardiovascular disease (e.g., heart block, uncontrolled hypertension, ischemic heart disease, severe valvular disease, chronic renal failure, or liver cirrhosis)
- •History of opioid or substance abuse
- •Emergency surgical procedures
- •Procedures expected to exceed 3 hours or requiring conversion to general anesthesia
研究组 & 干预措施
Group C: Bupivacaine Control
Patients undergo ultrasound-guided ilioinguinal-iliohypogastric nerve block immediately following spinal anesthesia with a total injectate volume of 10 mL consisting of 8 mL 0.5% bupivacaine (40 mg) and 2 mL sterile normal saline (final bupivacaine concentration 0.4%).
干预措施: Bupivacaine (Drug)
Group N: Nalbuphine Adjuvant
Patients undergo ultrasound-guided ilioinguinal-iliohypogastric nerve block immediately following spinal anesthesia with a total injectate volume of 10 mL consisting of 8 mL 0.5% bupivacaine (40 mg) and nalbuphine 10 mg diluted with sterile normal saline to 10 mL (final bupivacaine concentration 0.4%).
干预措施: Bupivacaine (Drug)
Group D: Dexmedetomidine Adjuvant
Patients undergo ultrasound-guided ilioinguinal-iliohypogastric nerve block immediately following spinal anesthesia with a total injectate volume of 10 mL consisting of 8 mL 0.5% bupivacaine (40 mg) and dexmedetomidine 1 µg/kg diluted with sterile normal saline to 10 mL (final bupivacaine concentration 0.4%).
干预措施: Dexmedetomidine (Drug)
Group N: Nalbuphine Adjuvant
Patients undergo ultrasound-guided ilioinguinal-iliohypogastric nerve block immediately following spinal anesthesia with a total injectate volume of 10 mL consisting of 8 mL 0.5% bupivacaine (40 mg) and nalbuphine 10 mg diluted with sterile normal saline to 10 mL (final bupivacaine concentration 0.4%).
干预措施: Nalbuphine (Drug)
Group D: Dexmedetomidine Adjuvant
Patients undergo ultrasound-guided ilioinguinal-iliohypogastric nerve block immediately following spinal anesthesia with a total injectate volume of 10 mL consisting of 8 mL 0.5% bupivacaine (40 mg) and dexmedetomidine 1 µg/kg diluted with sterile normal saline to 10 mL (final bupivacaine concentration 0.4%).
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Time to First Rescue Analgesia
时间窗: Up to 24 hours postoperatively
Time in minutes from the documented regression of spinal sensory block to the T12 dermatome until the patient's first request for rescue analgesia, administered when the Visual Analog Scale (VAS) pain score is 4 or greater (scale of 0 = no pain to 10 = worst imaginable pain).
次要结局
未报告次要终点
研究者
Mohammed Ayman Abd El-khaleq
Resident
Assiut University