Superficial Cervical Plexus Block for Improved Outcomes in Pediatric Otolaryngologic Surgery

ANES-2023-31691

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.

2023-01-03

2025-04-01

2025-04-01

Recruiting

Early phase I

36

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 36, 'type': 'ESTIMATED'}}

2024-01-08