Scalp Block Decreases Pain and Side Effects

Completed

• Conditions: Pain, Postoperative; Craniosynostoses
• Interventions: Other: scalp block

• Registration Number: NCT04133467
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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).

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2016-06-30
• Study Completion: 2016-06-30
• Status Verified: 2019-10
• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-10-17
• Last Update Submitted: 2019-10-19
• Study First Posted: 2019-10-21
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group SB	scalp block	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).

Primary Outcome Measures

Name	Time	Method
pain intensity	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 Outcome Measures

Name	Time	Method
resumption of oral nutrition	first postoperative day	evaluation of post-operative feeding recovery time

Trial Locations

Locations (1)

Rossano Festa; 🇮🇹 Roma, Italy