36 Participants Needed

Nerve Block for Pediatric ENT Surgery

CN
Overseen ByCandace Nelson
Age: < 65
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Minnesota
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

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 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.12345

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.12567

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.23678

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.

Research Team

BF

Benjamin Fuller, MD

Principal Investigator

University of Minnesota

Eligibility Criteria

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.
See 7 more

Timeline

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group1Experimental Treatment1 Intervention
Group II: Group 2Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Findings from Research

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.
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.
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.
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]

References

Evaluating the Analgesic Efficacy of Superficial Cervical Plexus Block for Head and Neck Surgeries: A Comparative Randomized Control Study. [2023]
Use of Ultrasound-Guided Superficial Cervical Plexus Block for Pain Management in the Emergency Department. [2022]
Superficial Cervical Plexus Block in Selective Cases of Oral and Maxillofacial Surgery as an Alternative to General Anesthesia: A Case Presentation. [2022]
Effect of superficial cervical plexus block on postoperative quality of recovery after anterior cervical discectomy and fusion: a randomized controlled trial. [2015]
Bilateral cervical plexus block for anterior cervical spine surgery: study protocol for a randomised placebo-controlled trial. [2022]
Horner's Syndrome after Superficial Cervical Plexus Block. [2022]
Comparison between general anesthesia and superficial cervical plexus block in partial thyroidectomies. [2022]
Ultrasound guided superficial cervical plexus block versus greater auricular nerve block for postoperative tympanomastoid surgery pain: A prospective, randomized, single blind study. [2019]
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