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

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is the superficial cervical plexus block (SCPB) generally safe for use in humans?

The superficial cervical plexus block (SCPB) is generally considered safe with minimal side effects, but rare complications like Horner's syndrome (a temporary condition affecting the eye and face) can occur. ^{1 2 3 4 5}

How does the nerve block treatment for pediatric ENT surgery differ from other treatments?

The nerve block treatment, specifically the superficial cervical plexus block (SCPB), is unique because it uses ultrasound guidance to target specific nerves in the neck region, providing localized pain relief without the need for general anesthesia. This approach can reduce the risks and recovery time associated with general anesthesia, making it a potentially safer option for children undergoing ENT surgery. ^{2 3 5 6 7}

What data supports the effectiveness of the treatment Superficial Cervical Plexus Block (SCPB) for pediatric ENT surgery?

Research shows that the Superficial Cervical Plexus Block (SCPB) is effective in providing pain relief for various head and neck surgeries, reducing the need for additional pain medication and improving recovery quality. It has been successfully used in surgeries involving the neck and jaw areas, suggesting it could be beneficial for pediatric ENT surgeries as well. ^{1 3 4 6 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

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]

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]

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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Evaluating the Analgesic Efficacy of Superficial Cervical Plexus Block for Head and Neck Surgeries: A Comparative Randomized Control Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Use of Ultrasound-Guided Superficial Cervical Plexus Block for Pain Management in the Emergency Department. [2022]

3. United States 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. [2022]

4. United States 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. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Bilateral cervical plexus block for anterior cervical spine surgery: study protocol for a randomised placebo-controlled trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Horner's Syndrome after Superficial Cervical Plexus Block. [2022]

7. Brazil pubmed.ncbi.nlm.nih.gov

Comparison between general anesthesia and superficial cervical plexus block in partial thyroidectomies. [2022]

8. Turkey 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. [2019]