Superficial Cervical Plexus Block for Improved Outcomes in Pediatric Otolaryngologic Surgery

Study Overview
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Brief Summary
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Literature on the use of superficial cervical plexus blocks for ear surgery is sparse in general, and almost non-existent in the pediatric population. Overall, literature review supports the safety of performance of this block but there is minimal published literature on its utility despite anecdotal evidence of benefit. This study, especially its prospective randomized nature will allow for expansion of the evidence for or against addition of this block to the care of pediatric patients undergoing ear surgery. The purpose of this study is to determine if SCPB plus standard practices provides superior pain control, as measured by reduced opiate consumption, compared to standard practices alone when performed on pediatric patients undergoing surgery on the ear and mastoid process.

Official Title
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Superficial Cervical Plexus Block for Improved Outcomes in Pediatric Otolaryngologic Surgery

Conditions
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Otolaryngologic Surgery

Intervention / Treatment
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* Drug: ropivacaine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: <18 years and >3 months Surgical procedure: Unilateral cochlear implant or tympanomastoidectomy Exclusion Criteria: Preoperative opiate use within the last 30 days Bilateral surgery No English speaking caregiver Parental/patient refusal Severe preoperative respiratory compromise Allergy to ropivacaine Coagulopathy: Defined by INR&gt;1.5 or Platelet count &lt;100k Current Infection at site of injection VP Shunt on side of surgical procedure Pregnant patients: determined by patient history and available laboratory data. Patients will not be required to have pregnancy testing done if not otherwise indicated.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group1<br> | Drug: ropivacaine<br>* will receive SCPB with ropivacaine via regional anesthesia team<br>|
| Placebo Comparator: Group 2<br> | Drug: Saline<br>* will receive SCPB with saline via regional anesthesia team<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid use | measured on a MME per kilogram | 30 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative opiate use | Assessed via chart review of opiate administration on an MME basis | 30 days post surgery | 
| post-operative opiate use |  | 30 days post surgery | 
| Pain level | Pain level will be assessed via total pain scores via either FLACC or Wong-Baker Faces, both are pain scales from 0-10, 0 being no pain and 10 being the worst pain imaginable. These scales are interchangeable and will allow both patients who can read and younger patients who cannot read to rate their pain. | 30 days post surgery | 
| Quality of Recovery | Assessed via modified version of the quality of recovery survey. The quality of recovery scale is a validated document for assessing recovery after surgery. The study will use a modified version of this with language changed for parental assessment of Quality of recovery, but the same questions and scale are used. | 30 days post surgery | 
| Post Anesthesia Care Unit anti-emetic use | Assessed via chart review of post-operative care unit medication administration | 30 days post surgery |