Otolaryngologic SurgeryPhase 4NCT06023329
Superficial Cervical Plexus Block for Improved Outcomes in Pediatric Otolaryngologic Surgery
A Phase 4 study testing ropivacaine and Saline in people with Otolaryngologic Surgery, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Otolaryngologic Surgery
- What is being tested?
- ropivacaine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2024to 1 May 2027
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: <18 years and >3 months
- Surgical procedure: Unilateral cochlear implant or tympanomastoidectomy
Who cannot join
- Preoperative opiate use within the last 30 days
- Bilateral surgery
- No English speaking caregiver
- Parental/patient refusal
- Severe preoperative respiratory compromise
- Allergy to ropivacaine
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
- Conditions
- Otolaryngologic Surgery
- Being tested
- ropivacaine, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineDrug
will receive SCPB with ropivacaine via regional anesthesia team
SalineDrug
will receive SCPB with saline via regional anesthesia team
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Experimental | Not described Receives: Drug: ropivacaine |
| Group 2 | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid use
measured on a MME per kilogram
Measured: 30 days post surgery
Secondary outcomes (5)
intraoperative opiate use
Assessed via chart review of opiate administration on an MME basis
Measured: 30 days post surgery
post-operative opiate use
Measured: 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.
Measured: 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.
Measured: 30 days post surgery
Post Anesthesia Care Unit anti-emetic use
Assessed via chart review of post-operative care unit medication administration
Measured: 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start31 May 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Why it stopped: The current PI is leaving the study. Study team is awaiting FDA PI change approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otolaryngologic SurgeryStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Fuller, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023329
- Sponsor's protocol ID
- ANES-2023-31691
- Status last verified
- May 2026
- First submitted
- 8 Aug 2023
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superficial Cervical Plexus Block for Improved Outcomes in Pediatric Otolaryngologic Surgery
- ClinicalTrials.gov ID
- NCT06023329
- Acronym / sponsor ID
- ANES-2023-31691
- Conditions
- Otolaryngologic Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The current PI is leaving the study. Study team is awaiting FDA PI change approval.
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 31 May 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 | Experimental | Drug: ropivacaine |
| Group 2 | Placebo comparator | Drug: Saline |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age: <18 years and >3 months
- Surgical procedure: Unilateral cochlear implant or tympanomastoidectomy
Key exclusion criteria (10 listed)
- Preoperative opiate use within the last 30 days
- Bilateral surgery
- No English speaking caregiver
- Parental/patient refusal
- Severe preoperative respiratory compromise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ropivacainewill receive SCPB with ropivacaine via regional anesthesia team | Drug | Group1 |
| Salinewill receive SCPB with saline via regional anesthesia team | Drug | Group 2 |
Primary outcome
Opioid use
Time frame: 30 days post surgery
measured on a MME per kilogram
5 secondary outcomes
intraoperative opiate use
Time frame: 30 days post surgery
post-operative opiate use
Time frame: 30 days post surgery
Pain level
Time frame: 30 days post surgery
Quality of Recovery
Time frame: 30 days post surgery
Post Anesthesia Care Unit anti-emetic use
Time frame: 30 days post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Fuller, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ropivacaine and Saline in people with Otolaryngologic Surgery, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid use (time frame: 30 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.