Clinical trial NCT04051723: Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-Craniotomy Pain in Children
Official title: Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-Craniotomy Pain in Children
Conditions: Pain, Postoperative
Children
Summary: 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. Researchers have clarified that the addition of dexamethasone to local infiltration of analgesia could provide significant analgesic effects and significantly prolong the duration of analgesic effects without obvious complications for various types of surgeries. To date, no studies have evaluated the addition of dexamethasone to local infiltration for patients receiving craniotomy. Thus, investigators suppose that pre-emptive scalp infiltration with steroid (Dexamethasone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children.
Interventions:
description: The local infiltration solution containing 0.25mg Dexamethasone and 2mg ropivacaine per milliliter. 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.
name: The dexamethasone plus ropivacaine
type: Drug
description: The local infiltration solution containing 2mg ropivacaine per milliliter. 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.
name: The ropivacaine
type: Drug
Study arms:
design_group_description: Patients in the dexamethasone plus ropivacaine group will receive a peri-incisional scalp infiltration with 0.025% dexamethasone and 0.2% ropivacaine and normal saline miscible liquids.
design_group_title: The dexamethasone plus ropivacaine group
design_group_type: Experimental
design_group_description: Patients in the ropivacaine group will receive a peri-incisional scalp infiltration with 0.2% ropivacaine and normal saline miscible liquids.
design_group_title: The ropivacaine group
design_group_type: Active Comparator
Sponsor: Beijing Tiantan Hospital
Collaborators: Beijing Children Hospital Group Co. Ltd.
Drug name mappings:
name: 盐酸罗哌卡因
lang: CN
name: Ropivacaine Hydrochloride
lang: EN
name: ロピバカイン塩酸塩水和物
lang: JP
name: 地塞米松
lang: CN
name: Dexamethasone
lang: EN
name: デキサメタゾン
lang: JP