Otolaryngologic Surgery
Conditions
Brief summary
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.
Interventions
DRUGropivacaine
will receive SCPB with ropivacaine via regional anesthesia team
DRUGSaline
will receive SCPB with saline via regional anesthesia team
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 18 Years
Healthy volunteers
No
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\>1.5 or Platelet count \<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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid use | 30 days post surgery | measured on a MME per kilogram |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative opiate use | 30 days post surgery | Assessed via chart review of opiate administration on an MME basis |
| post-operative opiate use | 30 days post surgery | — |
| Pain level | 30 days post surgery | 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. |
| Quality of Recovery | 30 days post surgery | 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. |
| Post Anesthesia Care Unit anti-emetic use | 30 days post surgery | Assessed via chart review of post-operative care unit medication administration |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBenjamin Fuller, MD
University of Minnesota
Outcome results
None listed