Nerve Block for Cleft Palate Pain Control

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Florida

Disqualifiers: Chronic pain, Revision surgery, others

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

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage pain after cleft palate surgery, which typically requires many opioids for relief. Researchers are examining whether a nerve block with ropivacaine (Naropin) can better control pain, enabling patients to eat and leave the hospital sooner. The study includes two groups: one receives the nerve block, while the other undergoes a sham procedure without the actual injection. This trial suits patients undergoing their first cleft palate surgery, who eat and drink normally before surgery, and do not have chronic pain issues. As a Phase 4 trial, the research aims to understand how this already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.

What is the safety track record for these treatments?

Research has shown that ropivacaine is generally safe and effective for managing pain after cleft palate surgery. Studies have found that applying ropivacaine directly to the surgical area provides effective pain relief for children. Importantly, no major side effects have been reported with this method.

Additional research suggests that numbing specific nerves around the surgical area, known as perioperative nerve blocks, can reduce complications. This makes them a helpful addition to general anesthesia for surgeries like cleft lip repair.

Overall, the evidence supports ropivacaine as a safe and effective choice for pain control in cleft palate surgeries, with minimal risk of serious side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard pain management for cleft palate surgery, which often relies on systemic drugs like opioids and acetaminophen, this approach uses a targeted technique called the suprazygomatic maxillary nerve blockade. This method involves directly injecting ropivacaine into the pterygopalatine fossa, aiming to block nerve signals and reduce pain at its source. Researchers are excited about this because it could offer more effective pain control with fewer side effects, as it minimizes the need for systemic medication and focuses the anesthetic effect precisely where it's needed. Additionally, the use of ropivacaine, known for its long-lasting effects and lower toxicity compared to other local anesthetics, enhances the potential benefits of this treatment.

What evidence suggests that this nerve block technique is effective for cleft palate pain control?

In this trial, participants may receive a suprazygomatic maxillary nerve blockade with ropivacaine. Studies have shown this method effectively manages pain after cleft palate surgery, providing good relief without major side effects. Specifically, ropivacaine in nerve blocks can reduce the need for opioids, which are strong painkillers with potential side effects. Research indicates that ropivacaine helps children recover faster by improving pain control, enabling them to start eating sooner, and shortening their hospital stay. This treatment is already approved for pain management, demonstrating its effectiveness in similar situations. ^{3 6 7 8 9}

Who Is on the Research Team?

Cameron Smith, MD, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for children needing surgery to repair a cleft palate, who can eat and drink normally before the operation, and don't have chronic pain conditions. It's not for those needing additional surgeries beyond palatoplasty or with factors that make nerve block placement or research participation risky as judged by the study team.

Inclusion Criteria

I am having surgery to repair a cleft palate only.

Parent/guardian consents to participate

Normal oral food and water intake before surgery

Exclusion Criteria

I need surgery for my palate that may include other procedures to help with my speech.

Parent/guardian refuses to consent

I need a second surgery on my palate.

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 a sham comparator or suprazygomatic maxillary nerve blockade

1 day

Post-operative Monitoring

Participants are monitored for pain control, opioid use, and time to oral intake post-surgery

96 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ropivacaine
• Sham Comparator

Trial Overview The study tests if blocking nerves near the midface with Ropivacaine provides better post-surgery pain relief compared to a sham treatment. The goal is to see if this method improves recovery time, reduces pain more effectively, and allows quicker return to normal eating which may lead to an earlier hospital discharge.

How Is the Trial Designed?

Group I: Suprazygomatic maxillary nerve blockade Experimental Treatment 1 Intervention

A single injection into the pterygopalatine fossa bilaterally of 0.2% ropivacaine at a dose of 0.15 mL/kg (block) after the induction of general anesthesia.

Group II: 25 Gauge needle Placebo Group 1 Intervention

Subcutaneous placement of a 25 Gauge needle as a sham comparator after the induction of general anesthesia. Nothing will be injected.

Ropivacaine is already approved in European Union, United States, Canada, China for the following indications:

Approved in European Union as Naropin for:

• Surgical anesthesia
• Pain relief

Approved in United States as Naropin for:

• Surgical anesthesia
• Pain relief

Approved in Canada as Naropin for:

• Surgical anesthesia
• Pain relief

Approved in China as Naropin for:

• Surgical anesthesia
• Pain relief

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

Ultrasound-guided suprazygomatic maxillary nerve blocks were successfully performed in 25 children undergoing cleft palate repair, with a high success rate of local anesthetic spread observed in 94% of cases.

The procedure demonstrated low pain scores and minimal opioid use, with 80% of patients not requiring continuous opioid infusion, indicating effective pain management and a good safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound guidance characteristics and efficiency of suprazygomatic maxillary nerve blocks in infants: a descriptive prospective study. Sola, C., Raux, O., Savath, L., et al.[2022]

In a study involving 60 children undergoing cleft palate repair, both levobupivacaine and bupivacaine were found to be equally effective for pain management, with no significant differences in pain scores or serious complications.

Bilateral maxillary nerve block (MNB) using either anesthetic provided effective pain relief, highlighting it as a safe and straightforward method for managing postoperative pain in children after cleft palate surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study of levobupivacaine and bupivacaine for bilateral maxillary nerve block during pediatric primary cleft palate surgery: a randomized double-blind controlled study. Mostafa, MF., Herdan, R., Elshazly, M.[2019]

The combined infraorbital and external nasal nerve blocks can effectively provide analgesia for cleft lip and palate repair, allowing procedures to be performed under local anesthesia without the need for general anesthesia or sedation in adolescents and adults.

This technique significantly reduces the need for postoperative opioid analgesia, particularly in children, thereby minimizing the risk of airway obstruction and other perioperative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined use of infraorbital and external nasal nerve blocks for effective perioperative pain control during and after cleft lip repair. Salloum, ML., Eberlin, KR., Sethna, N., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11420763/

Perioperative pain management for cleft palate surgery Effective pain control can decrease stress and agitation in children undergoing cleft palate surgery and improve surgical outcomes. However ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468785524000041

Comparison of postoperative analgesia in children ... Local infiltration with ropivacaine effectively provided postoperative analgesia for children undergoing cleft palate repair without major side effects.

3. journals.lww.com journals.lww.com/bjoa/fulltext/2020/04030/evaluation_of_postoperative_analgesic_effects_of.7.aspx

Evaluation of Postoperative Analgesic Effects of... The analgesic effects of levobupivacaine are statistically better than ropivacaine in the infraorbital block in children who underwent cleft palate surgery.

4. withpower.com withpower.com/trial/early-phase-1-cleft-palate-10-2018-3e1f6

Nerve Block for Cleft Palate Pain Control In a study involving 60 children undergoing cleft palate repair, both levobupivacaine and bupivacaine were found to be equally effective for pain management, ...

5. researchgate.net researchgate.net/publication/26882286_Effects_of_Preoperative_Local_Ropivacaine_Infiltration_on_Postoperative_Pain_Scores_in_Infants_and_Small_Children_Undergoing_Elective_Cleft_Palate_Repair_Statistical_Considerations_to_Transform_Intere

Effects of Preoperative Local Ropivacaine Infiltration on ... We found that either PCEA or CEA with plain ropivacaine 0.2% provided adequate pain relief in children during the first 48-h postoperative ...

6. rapm.bmj.com rapm.bmj.com/content/49/9/635

Perioperative pain management for cleft palate surgery The aim of this review was to evaluate the available evidence and to develop recommendations for optimal pain management after cleft palate surgery.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12433080/

Summary of best evidence for enhanced recovery after ... This study included children undergoing congenital cleft lip and palate surgery who received perioperative ERAS interventions with evidence ...

8. journals.lww.com journals.lww.com/mjdy/fulltext/2024/17040/a_systematic_review_of_perioperative_nerve_blocks.2.aspx

A Systematic Review of Perioperative Nerve Blocks for ... There were fewer adverse outcomes linked with perioperative nerve blocks. Perioperative nerve blocks can be a useful adjunct to general anesthesia in cleft lip ...

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/pan.70019

Quality Improvement Protocol to Reduce Excessive ... Background. Primary cleft palate repair in infants is frequently associated with postoperative pain and respiratory complications.