Scalp Block Decreases Pain and Side Effects
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|ClinicalTrials.gov Identifier: NCT04133467|
Recruitment Status : Completed
First Posted : October 21, 2019
Last Update Posted : October 22, 2019
|Condition or disease||Intervention/treatment|
|Craniosynostoses Pain, Postoperative||Other: scalp block|
Several studies on craniosynostosis and the correlated risk factors have been published, the majority of them focusing on the perioperative management of blood losses and avoidance of haemorrhagic shock. Other issues related to anaesthetic management of the surgical correction of craniosynostosis are metabolic and electrolyte disturbances.
Even if craniosynostosis surgery is an invasive procedure, there is a current misconception that it would be associated with minimal pain, despite the extensive exhibition of the skull and periostea dissection. The Literature about the assessment and management of postoperative pain in this particular surgical setting is scarce. Assessment of pain in infants is challenging, and often relies on clinical observation. To date, there are no evaluative and therapeutic parameters globally accredited in this category of patients. The scalp nerve block (SNB) is a regional anaesthetic technique, performed since several years in children undergoing a variety of procedures, from neurosurgery to eye-nose-throat surgery.SNB has been proposed as a complement to the routine craniosynostosis anaesthetic protocol, and should be associated to a reduced need for opioids.
Thirteen patients, aged between 3 months and 2 years, undergoing cranioplasty for the correction of craniosynostosis were subjected to SNB (Group SB) with Levobupivacaine 0.125% (total dose 2 mg/kg), performed before awakening, in combination with intraoperative intravenous acetaminophen (15 mg/kg if body weight >10Kg, 7 mg/kg if body weight < 10 kg). The SNB procedure was performed using the modified Pinosky technique, with levobupivacaine 0,125%(10). A targeted infiltration of 0,75-2ml of local anaesthetic (LA) solution was done at multiple sites with a 23G needle.
This Group of patients were compared with another group of 13 patients, derived from our database, and treated with the traditional pharmacological approach given intraoperatively (intravenous acetaminophen according to the body weight, plus intravenous tramadol 1 mg/kg).
|Study Type :||Observational|
|Actual Enrollment :||26 participants|
|Official Title:||The Scalp Block for Postoperative Pain Control in Craniosynostosis Surgery: a Case Control Study|
|Actual Study Start Date :||January 1, 2016|
|Actual Primary Completion Date :||June 30, 2016|
|Actual Study Completion Date :||June 30, 2016|
Scalp block performed with Levobupivacaine 0.125% (total dose 2 mg/kg) in combination with intraoperative intravenous acetaminophen (15 mg/kg if body weight >10Kg, 7 mg/kg if body weight < 10 kg).
Other: scalp block
intravenous acetaminophen according to the body weight, plus intravenous tramadol 1 mg/kg)
Other Name: intravenous pharmacological approach
intravenous acetaminophen according to the body weight, plus intravenous tramadol 1 mg/kg
- pain intensity [ Time Frame: OPS was assessed until the fifth day of hospitalization. ]
Objective Pain Score incorporates four pain behaviors (crying, movement, agitation, and verbalization) and was evaluated at following times:
- 30 minutes after extubation (T0)
- 2 hours after extubation (T1)
- 4 hours after extubation (T2)
- 8 hours after extubation (T3)
- at discharge from Pediatric Intensive Care Unit (T4).
- at in the Neurosurgical ward OPS was assessed every eight hours, until the fifth day of hospitalization.
- resumption of oral nutrition [ Time Frame: first postoperative day ]evaluation of post-operative feeding recovery time
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133467
|Roma, Italy, 00168|
|Principal Investigator:||Rossano festa, MD||Fondazione Universitaria Policlinico Gemelli IRCCS roma Italia|