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Completed

NCT Number: NCT04133467

Scalp Block Decreases Pain and Side Effects

Postoperative analgesia after corrective surgery of paediatric craniosynostosis is crucial in term of short and long-term outcomes. The objective of this observational case- control study was to evaluate the effectiveness of an analgesic technique based on the scalp block versus traditional pharmacological approach.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing cranioplasty for the correction of craniosynostosis

Exclusion criteria

  • allergies to local anesthetics and/or analgesics
  • specific drug therapies (pain relievers, sedatives and/or epileptic)
  • denied consent to the study; development of postoperative intracranical bleeding and/or gastrointestinal bleeding
  • need of nasogastric tube
  • development of gastrointestinal infections.

Treatment and study plan

Scalp block

Other

intravenous acetaminophen according to the body weight, plus intravenous tramadol 1 mg/kg)

Other names: intravenous pharmacological approach

Primary outcomes

  1. 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.

Secondary outcomes

  1. resumption of oral nutrition

    Time frame: first postoperative day

    evaluation of post-operative feeding recovery time

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

The Scalp Block for Postoperative Pain Control in Craniosynostosis Surgery: a Case Control Study

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 21, 2019
Registry last updated
Oct 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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