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Scalp Block Decreases Pain and Side Effects

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04133467
Enrollment
26
Registered
2019-10-21
Start date
2016-01-01
Completion date
2016-06-30
Last updated
2019-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniosynostoses, Pain, Postoperative

Brief summary

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.

Detailed description

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).

Interventions

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

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Months to 2 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
pain intensityOPS 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

MeasureTime frameDescription
resumption of oral nutritionfirst postoperative dayevaluation of post-operative feeding recovery time

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026