Effect of Scalp Block on Intraoperative Hemodynamics and Postoperative Pain in Craniotomy Patients"

Официальное название

Efficacy of Scalp Block on Intraoperative Hemodynamic Responses and Postoperative Analgesia in Patients Undergoing Craniotomy

Обзор

The goal of this clinical trial is to learn if an ultrasound-guided scalp block can improve intraoperative hemodynamic stability and provide better postoperative pain relief in adult patients undergoing elective supratentorial craniotomy. The main questions it aims to answer are: Does ultrasound-guided scalp block reduce changes in heart rate and blood pressure during surgery compared with surgical site infiltration? Does ultrasound-guided scalp block decrease postoperative pain and opioid requirements in the first 24 hours after craniotomy? Researchers will compare patients receiving an ultrasound-guided scalp block to those receiving standard surgical site infiltration to see if the scalp block provides better perioperative hemodynamic control and postoperative analgesia. Participants will: Receive general anesthesia with either ultrasound-guided scalp block or surgical site infiltration Have heart rate, blood pressure, and other hemodynamic parameters monitored throughout surgery Receive standard postoperative pain management, with pain scores recorded at 0, 2, 6, 12, and 24 hours Receive opioids as needed based on pain scores, with total opioid consumption and time to first analgesic dose recorded Be monitored for adverse events, including nausea, vomiting, sedation, and block-related complications

Подробное описание

This clinical trial is designed to evaluate whether an ultrasound-guided scalp block improves outcomes in adult patients undergoing elective craniotomy. Craniotomy, a surgical procedure to access the brain, can be associated with significant pain and stress responses during and after surgery. Painful events such as intubation, placement of skull pins, skin incision, and manipulation of the scalp and dura can cause rapid increases in heart rate and blood pressure, which may be harmful, especially in patients with brain injuries or compromised cerebral blood flow.

Currently, these hemodynamic changes are often managed with general anaesthesia and systemic medications such as opioids. However, opioids can delay recovery, cause nausea and vomiting, and interfere with neurological assessments after surgery. Regional anaesthesia techniques, like a scalp block, can reduce the body's stress response to surgery, provide better pain relief, and decrease the need for systemic pain medications. Ultrasound guidance allows anesthesiologists to locate nerves more accurately and perform the block safely, reducing potential complications.

In this study, participants will be randomly assigned to one of two groups. One group will receive a standard surgical site infiltration with local anaesthetic, while the other group will receive an ultrasound-guided scalp block in addition to general anaesthesia. All participants will be closely monitored during surgery, with measurements of heart rate, blood pressure, and other vital signs taken at key points, including before induction, during intubation, at skull pin placement, at skin incision, and at skin closure.

After surgery, participants will receive routine pain management and will be monitored for the first 24 hours. Pain levels will be recorded at multiple time points, and the total use of opioid pain medications, time to first analgesic, and any side effects or complications will be documented.

The main goal of the study is to determine whether the ultrasound-guided scalp block can provide better control of heart rate and blood pressure during surgery and improve postoperative pain relief compared with surgical site infiltration. Secondary goals include assessing the amount of pain medication needed after surgery and the incidence of any side effects, such as nausea, vomiting, or sedation.

Results from this study may help improve patient comfort, reduce complications, and optimize pain management strategies for patients undergoing brain surgery.

Вмешательства

• Процедура Surgical site infiltration with plain bupivacaine
  Participants receiving this intervention will undergo local anesthetic infiltration at the planned surgical sites in addition to standard general anesthesia for elective supratentorial craniotomy. Drug: Bupivacaine 0.5% plain solution Dosage: 10-15 ml along the incision line plus 5 ml at each pin insertion site Dosage Form: Injectable solution Route: Subcutaneous and deep infiltration into the scalp Timing: Single administration immediately after induction of general anesthesia, prior to su
• Процедура Scalp block with plain bupivacaine
  Participants receiving this intervention will undergo ultrasound-guided regional nerve blockade of the scalp in addition to standard general anesthesia for elective supratentorial craniotomy. The procedure targets the supratrochlear, supraorbital, auriculotemporal, postauricular branches of the greater auricular nerve, and the greater, lesser, and third occipital nerves.

Первичные конечные точки

• Postoperative pain intensity by Numeric Rating Scale (NRS) [Срок оценки: Immediately after shifting to the recovery room, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours]
• Changes in heart rate (beats per minute) [Срок оценки: 1. Baseline 2. During surgery (Before Induction (T0) After Intubation (T1) After USB/SSI (T2) After the Scull pin insertion (T3) During skin incision (T4) During Dural Opening (T5) During skin closure (T6))]
• Change in Systoloic Blood Pressure (SBP) (in mmHg) [Срок оценки: 1. Baseline 2. During surgery (Before Induction (T0) After Intubation (T1) After USB/SSI (T2) After the Scull pin insertion (T3) During skin incision (T4) During Dural Opening (T5) During skin closure (T6))]
• Change in diastolic blood pressure (DBP) (in mmHg) [Срок оценки: 1. Baseline 2. During surgery (Before Induction (T0) After Intubation (T1) After USB/SSI (T2) After the Scull pin insertion (T3) During skin incision (T4) During Dural Opening (T5) During skin closure (T6))]
• Change in mean arteial pressure (MAP) (in mmHg) [Срок оценки: 1. Baseline 2. During surgery (Before Induction (T0) After Intubation (T1) After USB/SSI (T2) After the Scull pin insertion (T3) During skin incision (T4) During Dural Opening (T5) During skin closure (T6))]

Вторичные конечные точки (1)

• Total consumption of morphine sulfate(mg) in 24 hours [Срок оценки: 24 hours]

Критерии участия

Критерии включения

• Age 18-64 years.
• ASA (American Society of Anesthesiologists) physical status I or II.
• Patients scheduled for elective supratentorial craniotomy.
• BMI of 18 to 30 kg/m².
• GCS score of 9 to 15.

Критерии исключения

• Patient with instable blood pressure and heart rate.
• Known allergy or hypersensitivity to local anesthetics.
• Coagulation disorders or current anticoagulant therapy.
• Infection at the injection site or systemic infection.
• Patients with open skull defects.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Zetlaoui PJ, Gauthier E, Benhamou D. Ultrasound-guided scalp nerve blocks for neurosurgery: A narrative review. Anaesth Crit Care Pain Med. 2020 Dec;39(6):876-882. doi: 10.1016/j.accpm.2020.06.019. Epub 2020 Oct 8. PMID 33039656
• Yildiz K, Bicer C, Aksu R, Dogru K, Madenoglu H, Boyaci A. A comparison of 1 minimum alveolar concentration desflurane and 1 minimum alveolar concentration isoflurane anesthesia in patients undergoing craniotomy for supratentorial lesions. Curr Ther Res Clin Exp. 2011 Apr;72(2):49-59. doi: 10.1016/j.curtheres.2011.03.001. PMID 24648575
• Vadivelu N, Kai AM, Tran D, Kodumudi G, Legler A, Ayrian E. Options for perioperative pain management in neurosurgery. J Pain Res. 2016 Feb 10;9:37-47. doi: 10.2147/JPR.S85782. eCollection 2016. PMID 26929661
• Uyar AS, Yagmurdur H, Fidan Y, Topkaya C, Basar H. Dexmedetomidine attenuates the hemodynamic and neuroendocrinal responses to skull-pin head-holder application during craniotomy. J Neurosurg Anesthesiol. 2008 Jul;20(3):174-9. doi: 10.1097/ANA.0b013e318177e5eb. PMID 18580347
• Theerth KA, Sriganesh K, Reddy KM, Chakrabarti D, Umamaheswara Rao GS. Analgesia Nociception Index-guided intraoperative fentanyl consumption and postoperative analgesia in patients receiving scalp block versus incision-site infiltration for craniotomy. Minerva Anestesiol. 2018 Dec;84(12):1361-1368. doi: 10.23736/S0375-9393.18.12837-9. Epub 2018 Jul 9. PMID 29991223
• Theerth KA, Sriganesh K, Chakrabarti D, Reddy KRM, Rao GSU. Analgesia nociception index and hemodynamic changes during skull pin application for supratentorial craniotomies in patients receiving scalp block versus pin-site infiltration: A randomized controlled trial. Saudi J Anaesth. 2019 Oct-Dec;13(4):306-311. doi: 10.4103/sja.SJA_812_18. PMID 31572074
• Pinosky ML, Fishman RL, Reeves ST, Harvey SC, Patel S, Palesch Y, Dorman BH. The effect of bupivacaine skull block on the hemodynamic response to craniotomy. Anesth Analg. 1996 Dec;83(6):1256-61. doi: 10.1097/00000539-199612000-00022. PMID 8942596
• Paul A, Krishna HM. Comparison between intravenous dexmedetomidine and local lignocaine infiltration to attenuate the haemodynamic response to skull pin head holder application during craniotomy. Indian J Anaesth. 2015 Dec;59(12):785-8. doi: 10.4103/0019-5049.171558. PMID 26903671

Идентификаторы

NCT: NCT07496632 · #6026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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