Scalp Block Decreases Pain and Side Effects

October 19, 2019 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00168
        • Rossano Festa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • intravenous pharmacological approach
Group ST
intravenous acetaminophen according to the body weight, plus intravenous tramadol 1 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
OPS was assessed until the fifth day of hospitalization.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
resumption of oral nutrition
Time Frame: first postoperative day
evaluation of post-operative feeding recovery time
first postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Rossano festa, MD, Fondazione Universitaria Policlinico Gemelli IRCCS roma Italia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

June 30, 2016

Study Completion (ACTUAL)

June 30, 2016

Study Registration Dates

First Submitted

October 17, 2019

First Submitted That Met QC Criteria

October 17, 2019

First Posted (ACTUAL)

October 21, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2019

Last Update Submitted That Met QC Criteria

October 19, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024 (Other Grant/Funding Number: Rome Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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