Nerve Block for Cleft Palate Surgery

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Disqualifiers: Allergy to local anesthesia, prior palate surgery

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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 explores better ways to manage pain during cleft palate surgery by comparing two methods: direct numbing of the palate (local anesthetic infiltration) and a nerve block (a procedure that numbs specific nerves to reduce pain). The researchers aim to determine which method helps children recover more comfortably and quickly. Children undergoing their first cleft palate surgery at Ann & Robert H. Lurie Children's Hospital of Chicago can participate, provided they are not allergic to certain pain medications. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance surgical recovery for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, doctors used an ultrasound-guided nerve block to help young children manage pain during cleft palate surgery. The results showed it effectively relieved pain after the operation, with no serious safety issues. Another study found that this nerve block helped children recover faster by reducing their need for additional pain medication and allowing them to start eating sooner.

For numbing the palate, doctors often inject medicine to numb the surgical area. This method is considered safe when performed by trained professionals, and side effects are rare.

Both treatments appear to be well-tolerated by children, suggesting they are safe options for managing pain during cleft palate surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ultrasound-guided bilateral suprazygomatic maxillary nerve block because it offers a new way to manage pain during cleft palate surgery. Unlike traditional local anesthetic infiltration of the palate, this method uses ultrasound guidance to precisely target the maxillary nerve, potentially providing more effective and longer-lasting pain relief. Additionally, by using ropivacaine with this nerve block technique, there's the opportunity for enhanced safety and reduced side effects compared to other local anesthetics. This innovative approach could significantly improve surgical outcomes and comfort for young patients undergoing cleft palate repair.

What evidence suggests that this trial's treatments could be effective for pain control in cleft palate surgery?

Research has shown that an ultrasound-guided bilateral suprazygomatic maxillary nerve block, one of the treatments in this trial, can significantly aid children undergoing cleft palate surgery. This technique reduces the need for strong painkillers post-surgery and enhances recovery. The ultrasound-guided nerve block also improves pain control and decreases the risk of confusion or restlessness upon waking from anesthesia. This method appears promising for making recovery smoother and less painful for young patients. ^{1 6 7 8 9}

Who Is on the Research Team?

Arun K Gosain, MD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Are You a Good Fit for This Trial?

This trial is for children around 11 to 12 months old undergoing primary cleft palate repair at Ann & Robert H. Lurie Children's Hospital of Chicago during the study period.

Inclusion Criteria

My child is having cleft palate repair at Lurie Children's Hospital.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cleft palate repair with either local anesthetic infiltration or ultrasound-guided bilateral suprazygomatic maxillary nerve block

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for pain scores, perioperative analgesia requirements, and other outcomes

48 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Local anesthetic infiltration of the palate
• Ultrasound-guided bilateral suprazygomatic maxillary nerve block

Trial Overview The study compares two pain control methods during cleft palate surgery: local anesthetic infiltration of the palate and ultrasound-guided bilateral suprazygomatic maxillary nerve block, aiming to improve postoperative outcomes.

How Is the Trial Designed?

Group I: Ultrasound-guided bilateral suprazygomatic maxillary nerve block Experimental Treatment 1 Intervention

Patients randomized to this arm will receive an ultrasound-guided bilateral suprazygomatic maxillary nerve block using 0.15 ml/kg of 0.2% ropivacaine per side, for a total of 0.3 ml/kg immediately after induction of general anesthesia and prior to incision. Participants will also receive local infiltration of the palate with an equivalent injection volume of 0.9% saline with 1:400,000 epinephrine at 2 ml/kg. Pediatric anesthesiologists with fellowship training in regional anesthesia will perform the nerve block. Local anesthetic infiltration will be performed by one of four board-certified pediatric plastic and craniofacial surgeons during repair of the palate. Patients, parents, surgeons, and the anesthesiologist will not be blinded to the specific intervention group due to the nature of the procedures involved. Nurses and the two key personnel responsible for data collection and analysis will be blinded throughout the entirety of the study.

Group II: Local anesthetic infiltration of the palate Active Control 1 Intervention

Patients randomized to this arm will receive local infiltration of the palate using 0.125% bupivacaine + 1:400,000 epinephrine at a dose of 2 ml/kg intraoperatively. Local anesthetic infiltration will be performed by one of four board-certified pediatric plastic and craniofacial surgeons during repair of the palate. Patients, parents, surgeons, and the anesthesiologist will not be blinded to the specific intervention group due to the nature of the procedures involved. Nurses and the two key personnel responsible for data collection and analysis will be blinded throughout the entirety of the study.

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1748681525002967

Effectiveness of suprazygomatic maxillary nerve block on ... Suprazygomatic maxillary nerve block effectively reduces postoperative opioid use and improves recovery outcomes in pediatric cleft palate surgery.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11694882/

Efficacy of ultrasound-guided suprazygomatic maxillary ... We aimed to assess the role of suprazygomatic maxillary nerve (MN) block (SMB) guided by ultrasound (US) in lowering EA incidence and enhancing analgesia ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04909619

Suprazygomatic Maxillary Nerve Block in Cleft Palate ... The goal of our study is to evaluate outcomes following the two routes for anesthetic infiltration during cleft palate repair. If either technique is found to ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/11101849.2021.1953832

Ultrasound-guided suprazygomatic maxillary nerve block ... Bilateral suprazygomatic maxillary nerve block for cleft palate repair in children: a prospective, randomized, double-blind study versus placebo.

5. isrctn.com isrctn.com/ISRCTN10977452

The effect of bilateral ultrasound-guided maxillary nerve ... Data is collected on patients who have already undergone cleft palate surgery and had general anaesthesia and local anaesthetic block. Data includes pain scores ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11198960/

The Maxillary Nerve Block in Cleft Palate Care: A Review ... Results: Survey response rate was 18% (n=78). Thirty-five respondents (44.9%) used MNB for cleft palate surgery before the course ...

7. rapm.bmj.com rapm.bmj.com/content/50/Suppl_1/A325.1.full

P305 Ultrasound guided suprazygomatic maxillary nerve ... Methods A case series of 09 Pediatric patients ageing from 9 months to 18 months of age was done with ultrasound guided suprazygomatic maxillary nerve block ( ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12475030/

Demystifying the Suprazygomatic Maxillary Nerve Block in ... Objective. To consider the clinical anatomy, safety and effectiveness of the suprazygomatic maxillary nerve block in cleft palate surgery.

9. sciencedirect.com sciencedirect.com/science/article/pii/S111018491830028X

Bilateral suprazygomatic maxillary nerve block versus ... Ultrasound-guided bilateral SMB provided better postoperative analgesia and decreased rescue analgesic consumption and time to tolerate oral feeding compared ...