Nerve Block for Pediatric ENT Surgery

Overseen By Candace Nelson

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Minnesota

Must not be taking: Opiates

Disqualifiers: Bilateral surgery, Respiratory compromise, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called the Superficial Cervical Plexus Block, a type of nerve block, to determine if it reduces pain and the need for opiate painkillers after ear surgery in children. The study compares two groups: one receiving the nerve block with standard care and the other receiving a placebo with standard care. Suitable candidates for this trial include children undergoing a unilateral cochlear implant or tympanomastoidectomy, without recent opiate use or certain medical conditions. The goal is to determine if adding this nerve block improves pain management. As a Phase 4 trial, this research examines how an already FDA-approved and effective treatment can benefit more patients, potentially enhancing pain management strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used opiates in the last 30 days.

What is the safety track record for the Superficial Cervical Plexus Block?

Research has shown that the superficial cervical plexus block (SCPB) is generally safe and has few side effects. Rarely, it may cause temporary issues like Horner's syndrome, which leads to drooping eyelids and smaller pupils. One study found SCPB to be a low-risk anesthesia method, often used safely in head and neck surgeries. Overall, SCPB is well-tolerated in various procedures, making it a promising option for reducing pain in children's ear surgeries. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Superficial Cervical Plexus Block for pediatric ENT surgery because it offers a non-opioid, targeted pain relief option. Unlike standard treatments that often rely on systemic pain relievers like opioids, this nerve block focuses on numbing specific nerves in the neck area, potentially reducing the need for more generalized pain medications. This method could minimize side effects and enhance recovery times, making it a promising alternative to traditional pain management approaches in children undergoing surgery.

What evidence suggests that the Superficial Cervical Plexus Block is effective for pediatric ear surgery?

Research has shown that a type of anesthesia called the superficial cervical plexus block (SCPB) can reduce pain for children undergoing ear surgeries. In this trial, some participants will receive SCPB, while others will receive a placebo. One study found that SCPB significantly lowered the need for strong painkillers like fentanyl and paracetamol during and after surgery. Another study demonstrated that SCPB provided longer-lasting pain relief after surgery compared to not using the block. While these findings are promising, most research has involved adults, with only a few cases involving children, indicating SCPB's potential to reduce pain and the need for medication during surgeries near the head and neck. ^{2 4 6 7 8}

Who Is on the Research Team?

Benjamin Fuller, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for children older than 3 months and under 18 years who are having specific ear surgeries (like cochlear implant or tympanomastoidectomy). They can't join if they've used opiates recently, have severe breathing issues, are allergic to ropivacaine, need bilateral surgery, don't have an English-speaking caregiver, refuse to participate, have bleeding disorders or infections at the injection site.

Inclusion Criteria

I have had surgery for a cochlear implant or to treat an ear condition.

Exclusion Criteria

Allergy to ropivacaine

VP Shunt on side of surgical procedure

I am having or have had surgery on both sides of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgery with or without the superficial cervical plexus block

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including opioid use and recovery quality

30 days

Multiple assessments (in-person and chart review)

What Are the Treatments Tested in This Trial?

Interventions

• Superficial Cervical Plexus Block

Trial Overview The study tests whether a superficial cervical plexus block with ropivacaine plus standard care provides better pain control compared to just standard care in kids having ear surgery. It's a randomized trial which means patients will be randomly assigned to receive either the block with ropivacaine or saline as a comparison.

How Is the Trial Designed?

Group I: Group1 Experimental Treatment 1 Intervention

Group II: Group 2 Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

In a study of 27 emergency department patients, ultrasound-guided superficial cervical plexus block (SCPB) resulted in a significant average pain reduction of 5.4 points (62%) on an 11-point scale, indicating its potential efficacy for managing neck and shoulder pain.

The procedure was found to be safe, with no serious complications reported and only minor issues like self-limiting vocal hoarseness and asymptomatic hemi-diaphragmatic paresis, suggesting that SCPB could be a viable option for pain management in emergency settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Ultrasound-Guided Superficial Cervical Plexus Block for Pain Management in the Emergency Department. Ho, B., De Paoli, M.[2022]

A superficial cervical plexus block (SCPB) significantly improved the quality of recovery in patients undergoing elective anterior cervical discectomy and fusion (ACDF), as indicated by higher QoR-40 scores at 24 hours post-surgery.

Despite the benefits in recovery quality, the SCPB did not reduce postoperative opioid consumption or affect discharge times compared to patients who did not receive the block.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of superficial cervical plexus block on postoperative quality of recovery after anterior cervical discectomy and fusion: a randomized controlled trial. Mariappan, R., Mehta, J., Massicotte, E., et al.[2015]

Patients undergoing hemithyroidectomy with superficial cervical plexus block (SCPB) experienced no laryngotracheal injuries, while 51% of those under general anesthesia (GA) did, highlighting a significant safety advantage of SCPB.

SCPB resulted in lower treatment costs (R$87.4) compared to GA (R$203.2), although it required longer surgery and anesthesia times, indicating a trade-off between cost-effectiveness and procedural duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between general anesthesia and superficial cervical plexus block in partial thyroidectomies. Mamede, RC., Raful, H.[2022]

In a study of 50 patients undergoing tympanomastoid surgery, both ultrasound-guided superficial cervical plexus (SCP) block and greater auricular nerve (GAN) block were effective for postoperative pain control, with no significant differences in pain scores between the two methods.

However, patients receiving the SCP block required significantly less tramadol for pain management compared to those receiving the GAN block, suggesting that while SCP may be more effective in reducing opioid consumption, it carries a higher risk of serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound guided superficial cervical plexus block versus greater auricular nerve block for postoperative tympanomastoid surgery pain: A prospective, randomized, single blind study. Ökmen, K., Metin Ökmen, B.[2019]

The study investigates the effectiveness of bilateral superficial cervical plexus block (SCPB) in improving postoperative recovery for 136 patients undergoing anterior cervical spine surgery, focusing on pain management and recovery quality.

By comparing SCPB with a placebo in a blinded, randomized trial, the research aims to provide clear evidence on whether SCPB significantly reduces opioid use, hospital stay length, and postoperative complications like nausea and pain intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral cervical plexus block for anterior cervical spine surgery: study protocol for a randomised placebo-controlled trial. Mulcahy, MJ., Elalingam, T., Jang, K., et al.[2022]

The superficial cervical plexus block (SCPB) is an effective regional anesthetic technique for surgeries in the submandibular area, neck, and ear lobe, providing valuable pain management for various conditions.

A case study demonstrated the successful use of SCPB in a patient undergoing surgery for a non-union of a mandibular fracture, highlighting its safety and efficacy without complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Superficial Cervical Plexus Block in Selective Cases of Oral and Maxillofacial Surgery as an Alternative to General Anesthesia: A Case Presentation. Saripalli, RRK., Kasaraneni, S., Yadavilli, SS., et al.[2022]

The study found that superficial cervical plexus block (SCPB) significantly reduced the need for intraoperative fentanyl and postoperative paracetamol in patients undergoing head and neck surgeries, indicating its effectiveness in providing analgesia.

Patients receiving SCPB experienced a longer duration of analgesia (approximately 1191 minutes) compared to those who only received systemic analgesia (about 122 minutes), with no significant complications reported, highlighting its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Analgesic Efficacy of Superficial Cervical Plexus Block for Head and Neck Surgeries: A Comparative Randomized Control Study. Patel, H., Shah, N., Syed, A., et al.[2023]

Ultrasound-guided nerve blocks, like the superficial cervical plexus block (SCPB), are increasingly used in emergency departments to manage acute pain, such as from clavicle fractures.

This study reports the first case of Horner's syndrome, a rare complication, following an SCPB, highlighting the need for awareness of potential complications due to the complex anatomy of the neck.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Horner's Syndrome after Superficial Cervical Plexus Block. Flores, S., Riguzzi, C., Herring, AA., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39958327/

A Retrospective Analysis of Superficial Cervical Plexus ... Our objective was to determine whether superficial cervical plexus blockade reduced postoperative nausea and vomiting (PONV) in children undergoing otologic ...

2. withpower.com withpower.com/trial/phase-4-otolaryngologic-surgery-11-2023-66912

Nerve Block for Pediatric ENT Surgery · Info for Participants The study found that superficial cervical plexus block (SCPB) significantly reduced the need for intraoperative fentanyl and postoperative paracetamol in ...

3. researchgate.net researchgate.net/journal/Paediatric-and-Neonatal-Pain-2637-3807/publication/389009747_A_Retrospective_Analysis_of_Superficial_Cervical_Plexus_Blockade_for_Children_Undergoing_Otologic_Surgery/links/67b02ac0207c0c20fa8a44d1/A-Retrospective-Analysis-of-Superficial-Cervical-Plexus-Blockade-for-Children-Undergoing-Otologic-Surgery.pdf?origin=scientificContributions

A-Retrospective-Analysis-of-Superficial-Cervical-Plexus- ... ABSTRACT. Superficial cervical plexus blocks (SCPB) are well documented for anterior and lateral neck surgeries in adults. Their role in the pediatric ...

4. cureus.com cureus.com/articles/141953-evaluating-the-analgesic-efficacy-of-superficial-cervical-plexus-block-for-head-and-neck-surgeries-a-comparative-randomized-control-study

Evaluating the Analgesic Efficacy of Superficial Cervical ... We found that the total duration of analgesia was significantly higher in Group B (1191.33±375.36 minutes) as compared to Group A (122.0±50.88 ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/33/NCT02724033/Prot_SAP_000.pdf

Comparative Study of Superficial Cervical Plexus We would like to compare the therapeutic and cost effectiveness of established therapies for postoperative nausea and vomiting to regional nerve blocks of the ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/pne2.70002

A Retrospective Analysis of Superficial Cervical Plexus ... The results of this retrospective study do not demonstrate an association between placement of a SCPB and decreased PONV for children who ...

7. researchgate.net researchgate.net/publication/317958269_The_Safety_and_Effectiveness_of_Superficial_Cervical_Plexus_Block_in_Oral_and_Maxillofacial_Surgery_as_an_Alternative_to_General_Anesthesia_in_Selective_Cases_A_Clinical_Study

The Safety and Effectiveness of Superficial Cervical Plexus ... Conclusion: Superficial cervical plexus block anesthesia is a safe and useful anesthetic technique with the low risk of accidents and ...

8. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-025-02973-8

Esketamine combined with ultrasound-guided superficial ... This case report describes the successful management of a pediatric patient with congenital subglottic stenosis who underwent tracheotomy using esketamine ...