Safety and Efficacy of Addition of Hyaluronidase to Lidocaine and Bupivacaine in Scalp Nerves Block in Elective Craniotomy Operations, Comparative Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Post-operative pain evaluation
研究概览
简要总结
Safety and efficacy of addition of hyaluronidase to lidocaine and bupivacaine in scalp nerves block in elective craniotomy operations,Comparative study
详细描述
Patients undergoing craniotomy operations are susceptible to many injurious stimuli such as skin incision, insertion of cranial pins, dural incision, dural and skin closure. They cause different levels of nociception and these stimuli can result in sudden increases in blood pressure and heart rate due to triggering stress response.
Strategies to blunt these noxious stimuli and attenuate this stress response include administration of systemic opioids, deepening the level of anaesthesia. Scalp nerves block by local anaesthetics also can be used.
However, most systemically administered medications studied for post-craniotomy pain usually associated with side effects such as sedation, nausea, and vomiting and depressed ventilation such events are particularly important for post-craniotomy patients.
Using regional aesthetic techniques in addition to general anaesthesia have been conducted as multimodality managements for post-craniotomy pain and to decrease systemic administration of analgesics and hence decrease their systemic complications.
The stress response is the hormonal and metabolic changes that follow injury or trauma. This includes wide range of endocrinological and immunological effects. The stress response to surgery is characterized by increased secretion of pituitary hormones and activation of the sympathetic nervous system. Hypothalamic activation of the sympathetic autonomic nervous system results in increased secretion of catecholamines from the adrenal medulla and release of norepinephrine from presynaptic nerve terminals. IL-6 is produced in substantial quantities at the site of a surgical wound.IL-6 enters the circulation, and its concentration correlates with the severity of surgery and thus with the magnitude of the tissue injury. At 24 to 36 h after surgery, the levels of IL-6 in the plasma reach preoperative values, because its production is attenuated. Postoperative pain behaves like wound on plasma IL-6: intense postoperative pain correlates with the magnitude of tissue injury and subsides days after. Pain in the first 24 hours after brain surgery is a significant problem, with 60% to 80% of patients experiencing moderate to severe pain.
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
- Double (Participant, Investigator)
盲法说明
Prospective randomized double blinded clinical study on humans
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA Ι and II.
- •Both males and females, age (18-60) years.
- •Supine position.
- •Glasco coma scale more than
- •Elective craniotomy operations.
排除标准
- •ASA ΙII or IV
- •History of allergy to the study drugs.
- •Surgery to remove pituitary tumours or affecting pituitary hormones.
- •Glasco coma scale less than
- •The need for postoperative ventilation.
研究组 & 干预措施
Group H (Hyaluronidase added to local anaesthetics)
group H scalp block will be done using lidocaine (2%) in a maximum dose of 300 mg and bupivacaine (0.5%) with maximum allowed dose 175 mg , Hyaluronidase will be added in in a dose of 1500 IU . The scalp block technique includes infiltrating local anaesthetic to 7 nerves on either side. This is an anatomical block and not just a ring block. At the end of the scalp block further local anesthetic can be infiltrated locally to the pin sites and 7 nernes supraorbital nerve, a branch of the trigeminal nerve,supratrochlear nerve, a branch of the trigeminal nerve.
zygomaticotemporal nerve,auriculotemporal nerve, lesser occipital nerve, greater occipital nerve and greater auricular nerve
干预措施: Hyaluronidase (Drug)
Group H (Hyaluronidase added to local anaesthetics)
group H scalp block will be done using lidocaine (2%) in a maximum dose of 300 mg and bupivacaine (0.5%) with maximum allowed dose 175 mg , Hyaluronidase will be added in in a dose of 1500 IU . The scalp block technique includes infiltrating local anaesthetic to 7 nerves on either side. This is an anatomical block and not just a ring block. At the end of the scalp block further local anesthetic can be infiltrated locally to the pin sites and 7 nernes supraorbital nerve, a branch of the trigeminal nerve,supratrochlear nerve, a branch of the trigeminal nerve.
zygomaticotemporal nerve,auriculotemporal nerve, lesser occipital nerve, greater occipital nerve and greater auricular nerve
干预措施: Lidocaine (Drug)
Group H (Hyaluronidase added to local anaesthetics)
group H scalp block will be done using lidocaine (2%) in a maximum dose of 300 mg and bupivacaine (0.5%) with maximum allowed dose 175 mg , Hyaluronidase will be added in in a dose of 1500 IU . The scalp block technique includes infiltrating local anaesthetic to 7 nerves on either side. This is an anatomical block and not just a ring block. At the end of the scalp block further local anesthetic can be infiltrated locally to the pin sites and 7 nernes supraorbital nerve, a branch of the trigeminal nerve,supratrochlear nerve, a branch of the trigeminal nerve.
zygomaticotemporal nerve,auriculotemporal nerve, lesser occipital nerve, greater occipital nerve and greater auricular nerve
干预措施: Bupivacaine (Drug)
Group A (local anaesthetics alone)
Group A :scalp nerves block will be done using lidocaine (2%) in a maximum dose of 300 mg and bupivacaine (0.5%) with maximum dose of 175 mg The scalp block technique includes infiltrating local anaesthetic to 7 nerves on either side. This is an anatomical block, and not just a ring block. At the end of the scalp block; further local anesthetic can be infiltrated locally to the pin sites and 7 nernes Supraorbital nerve, a branch of the trigeminal nerve.
supratrochlear nerve, a branch of the trigeminal nerve. zygomaticotemporal nerve, auriculotemporal nerve, lesser occipital nerve, greater occipital nerve, greater auricular nerve
干预措施: Lidocaine (Drug)
Group A (local anaesthetics alone)
Group A :scalp nerves block will be done using lidocaine (2%) in a maximum dose of 300 mg and bupivacaine (0.5%) with maximum dose of 175 mg The scalp block technique includes infiltrating local anaesthetic to 7 nerves on either side. This is an anatomical block, and not just a ring block. At the end of the scalp block; further local anesthetic can be infiltrated locally to the pin sites and 7 nernes Supraorbital nerve, a branch of the trigeminal nerve.
supratrochlear nerve, a branch of the trigeminal nerve. zygomaticotemporal nerve, auriculotemporal nerve, lesser occipital nerve, greater occipital nerve, greater auricular nerve
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Post-operative pain evaluation
时间窗: up to 24 hours postoperatively
Post-operative VAS for pain post-operative.
次要结局
- Haemodynamic Measures(Every 5 minutes during operation In first 24 hours postoperatively)
- Interleukin 6 measurement(Interleukin 6 level will be measured before surgery (9:00 A.M),30 minutes after scalp nerves block, 60 minutes after skin incision and after 6 hours post-operative.)
- Intraoperative rescue dose of opioid(6 hours postoperative then every 2 hours for 24 hours.)
- Time of first analgesic request(Intraoperative)
- Haemodynamic effects(up to 24 hours postoperatively)
研究者
Ahmed Abdalla
Assistant Professor of Anesthesia&I.C.U and Pain Clinic, Cairo University
Cairo University