Not provided
Not provided
Not provided
Not provided
Not provided
The current PI is leaving the study. Study team is awaiting FDA PI change approval.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 | Experimental |
| |
| Group 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ropivacaine | Drug | will receive SCPB with ropivacaine via regional anesthesia team |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid use | measured on a MME per kilogram | 30 days post surgery |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Benjamin Fuller, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
Not provided
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Saline |
| Drug |
will receive SCPB with saline via regional anesthesia team |
|
| 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 |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |