Pre-emptive Scalp Infiltration with Triamcinolone Acetonide Plus Ropivacaine for Post-Craniotomy Pain in Children

Обзор

At present, pediatric postoperative analgesia has not been fully understood and controlled, particularly craniotomy surgery. On the one hand, professional evaluation of postoperative pain for young children is difficult; on the other hand, the particularity of craniotomy adds (such as consciousness obstacle, sleepiness, et al) disturbance to the pain assessment in children. Although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management, it may be associated with delayed awakening, respiratory depression, hypercarbia and it may interfere with the neurologic examination. For the avoidance of side-effects of systemic opioids, local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was unsatisfactory due to its short pain relief duration, steroid as adjuvant can enhance postoperative analgesia and prolong postoperative analgesia time. As is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles, preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction.However, there has not been reported about local application of triamcinolone acetonide on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (triamcinolone acetonide) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children.

Вмешательства

• Препарат The triamcinolone acetonide plus ropivacaine group
  The solution prepared comprised a mixture of 20mL of 0.2% ropivacaine(40mg) with 4 mg of triamcinolone acetonide. The assigned solution will be injected subcutaneously by surgeons along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigators.
• Препарат The ropivacaine group
  The local infiltration solution containing 20mg of 1% ropivacaine. The total volume is 20 ml. The assigned solution will be injected subcutaneously by surgeons along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigators.

Первичные конечные точки

• the Faces, Legs, Activity, Cry, Consolability (FLACC) scale [Срок оценки: At 24 hours after the operation]

Вторичные конечные точки (7)

• the Faces, Legs, Activity, Cry, Consolability (FLACC) scale [Срок оценки: At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week after surgery]
• Duration of analgesia [Срок оценки: Within 48 hours after the operation]
• The occurrence of postoperative nausea and vomiting (PONV) [Срок оценки: At 2 hours, 4 hours, 8 hours, 24 hours after surgery]
• Incisional related adverse events [Срок оценки: Approximately 1 weeks after the operation]
• The occurrence of the Adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: Within 1 weeks after the operation]
• Patient satisfactory scale (PSS) [Срок оценки: At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week after surgery]
• The total consumption of opioids during the operation [Срок оценки: During procedure]

Критерии участия

Критерии включения

-(1) Age 2 to 12 years. (2) American Society of Anesthesiologists (ASA) physical status I or II. (3)Participates with an anticipated fully recovery within 2 hours postoperatively.

(4)Informed consent by parent(s) and/or legal guardian.

Критерии исключения

\- (1) Allergy to local anesthetics. (2) Pediatric patients aged>12 or <2 years. (3) Under medication with analgesic drugs. (4) Psychiatric disorders. (5) Uncontrolled epilepsy. (6) Chronic headache. (7) Peri-incisional infection. (8) Coagulopathy or bleeding disorder. (9) Patients who are expected to remain intubated and mechanical ventilation after surgery.

(10) Emergency craniotomies. (11) Patients with cardiac insufficiency or severe kidney or liver diseases. (12) Patients whose authorized surrogates are unwilling to participate in the study

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

Двойное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital — Пекин

Идентификаторы

NCT: NCT06779396 · KY 2018-066-02-4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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