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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Craniosynostoses Pain, Postoperative Other: scalp block

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).


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Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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


Group/Cohort Intervention/treatment
Group SB
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

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



Primary Outcome Measures :
  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 Outcome Measures :
  1. resumption of oral nutrition [ Time Frame: first postoperative day ]
    evaluation of post-operative feeding recovery time



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Ages Eligible for Study:   3 Months to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with aged between 3 months and 2 years, undergoing cranioplasty for the correction of craniosynostosis
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133467


Locations
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Italy
Rossano Festa
Roma, Italy, 00168
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
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Principal Investigator: Rossano festa, MD Fondazione Universitaria Policlinico Gemelli IRCCS roma Italia

Publications:
Stricker PA, Goobie SM, Cladis FP, Haberkern CM, Meier PM, Reddy SK, Nguyen TT, Cai L, Polansky M, Szmuk P, Fiadjoe J, Soneru C, Falcon R, Petersen T, Kowalczyk-Derderian C, Dalesio N, Budac S, Groenewald N, Rubens D, Thompson D, Watts R, Gentry K, Ivanova I, Hetmaniuk M, Hsieh V, Collins M, Wong K, Binstock W, Reid R, Poteet-Schwartz K, Gries H, Hall R, Koh J, Bannister C, Sung W, Jain R, Fernandez A, Tuite GF, Ruas E, Drozhinin O, Tetreault L, Muldowney B, Ricketts K, Fernandez P, Sohn L, Hajduk J, Taicher B, Burkhart J, Wright A, Kugler J, Barajas-DeLoa L, Gangadharan M, Busso V, Stallworth K, Staudt S, Labovsky KL, Glover CD, Huang H, Karlberg-Hippard H, Capehart S, Streckfus C, Nguyen KT, Manyang P, Martinez JL, Hansen JK, Levy HM, Brzenski A, Chiao F, Ingelmo P, Mujallid R, Olutoye OA, Syed T, Benzon H, Bosenberg A; Pediatric Craniofacial Collaborative Group. Perioperative Outcomes and Management in Pediatric Complex Cranial Vault Reconstruction: A Multicenter Study from the Pediatric Craniofacial Collaborative Group. Anesthesiology. 2017 Feb;126(2):276-287. doi: 10.1097/ALN.0000000000001481.

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Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT04133467     History of Changes
Other Study ID Numbers: 2024
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Craniosynostoses
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Synostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Congenital Abnormalities
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics