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CraniosynostosesNCT04133467

Scalp Block Decreases Pain and Side Effects

An observational study of Craniosynostoses and Pain, Postoperative, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 months to 2 years
Conditions the study is for
Craniosynostoses, Pain, Postoperative
What is being tested?
scalp block
Type of treatment
Injection or infusion
How many people
26 participants
Where
1 siteItaly
Study dates
1 Jan 2016to 30 Jun 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 months to 2 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: patients with aged between 3 months and 2 years, undergoing cranioplasty for the correction of craniosynostosis

Who may be able to join

  • patients undergoing cranioplasty for the correction of craniosynostosis

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Rossano Festa

    Roma, 00168

Other trials in Italy

About this study

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

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.

Read the 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).

Being tested
scalp block
Medical subject headings
Craniosynostoses, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • scalp blockOther

    Also called intravenous pharmacological approach

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

Study groups in NCT04133467
Study groupRoleWhat they receive
Group SBScalp 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).
Receives: Other: scalp block
Group STintravenous acetaminophen according to the body weight, plus intravenous tramadol 1 mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain intensity

    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.

    Measured: OPS was assessed until the fifth day of hospitalization.

Secondary outcomes (1)

  1. resumption of oral nutrition

    evaluation of post-operative feeding recovery time

    Measured: first postoperative day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2019
  2. Study start1 Jan 2016
  3. Primary completion30 Jun 2016
  4. Study completion30 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04133467
Sponsor's protocol ID
2024
Status last verified
Oct 2019
First submitted
17 Oct 2019
Last updated
22 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 27977460

  • Thomas K, Hughes C, Johnson D, Das S. Anesthesia for surgery related to craniosynostosis: a review. Part 1. Paediatr Anaesth. 2012 Nov;22(11):1033-41. doi: 10.1111/j.1460-9592.2012.03927.x.

    PubMed 22928738

  • Chiaretti A, Pietrini D, Piastra M, Polidori G, Savioli A, Velardi F, Ciano F, Di Rocco C. Safety and efficacy of remifentanil in craniosynostosis repair in children less than 1 year old. Pediatr Neurosurg. 2000 Aug;33(2):83-8. doi: 10.1159/000028981.

    PubMed 11070434

  • Teo JH, Palmer GM, Davidson AJ. Post-craniotomy pain in a paediatric population. Anaesth Intensive Care. 2011 Jan;39(1):89-94. doi: 10.1177/0310057X1103900115.

    PubMed 21375097

  • Guilfoyle MR, Helmy A, Duane D, Hutchinson PJA. Regional scalp block for postcraniotomy analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 May;116(5):1093-1102. doi: 10.1213/ANE.0b013e3182863c22. Epub 2013 Mar 11.

    PubMed 23477962

  • Pinosky ML, Fishman RL, Reeves ST, Harvey SC, Patel S, Palesch Y, Dorman BH. The effect of bupivacaine skull block on the hemodynamic response to craniotomy. Anesth Analg. 1996 Dec;83(6):1256-61. doi: 10.1097/00000539-199612000-00022.

    PubMed 8942596

  • Pardey Bracho GF, Pereira de Souza Neto E, Grousson S, Mottolese C, Dailler F. Opioid consumption after levobupivacaine scalp nerve block for craniosynostosis surgery. Acta Anaesthesiol Taiwan. 2014 Jun;52(2):64-9. doi: 10.1016/j.aat.2014.05.006. Epub 2014 Jun 21.

    PubMed 25016510

  • Phillips S, Gift M, Gelot S, Duong M, Tapp H. Assessing the relationship between the level of pain control and patient satisfaction. J Pain Res. 2013 Sep 9;6:683-9. doi: 10.2147/JPR.S42262. eCollection 2013.

    PubMed 24049457

  • Festa R, Tosi F, Pusateri A, Mensi S, Garra R, Mancino A, Frassanito P, Rossi M. The scalp block for postoperative pain control in craniosynostosis surgery: a case control study. Childs Nerv Syst. 2020 Dec;36(12):3063-3070. doi: 10.1007/s00381-020-04661-z. Epub 2020 May 17.

    PubMed 32418049

Questions about this trial

What is this clinical trial studying?

An observational study of Craniosynostoses and Pain, Postoperative, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain intensity (time frame: OPS was assessed until the fifth day of hospitalization.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04133467, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019; AzTrials last refreshed its copy on 26 Oct 2026.

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