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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug Ropivacaine for cleft palate pain control?

Research shows that using Ropivacaine before cleft palate surgery in infants and small children can significantly reduce pain after the operation compared to not using any medication. This suggests that Ropivacaine is effective in managing postoperative pain in these patients. ^{1 2 3 4 5}

Is the nerve block for cleft palate pain control safe for humans?

The studies reviewed suggest that nerve blocks, such as the greater palatine nerve block, are generally safe and effective for pain control in cleft palate surgeries, with fewer side effects compared to opioid use. They help reduce the need for opioids, which can cause breathing problems, and have been successfully used in children and adults. ^{1 2 3 6 7}

How does the drug Ropivacaine differ from other treatments for cleft palate pain control?

Ropivacaine, used in nerve blocks for cleft palate pain control, is unique because it provides targeted pain relief by numbing specific nerves, potentially reducing the need for opioids, which can cause breathing problems in children after surgery. This approach may offer a safer alternative to traditional pain management methods that rely heavily on opioids. ^{1 2 3 8 9}

What is the purpose of this trial?

Cleft palate repair requires high doses of opioids for pain control postop. An alternative approach is placement of nerve blocks in the pterygopalatine fossa bilaterally, blocking the maxillary nerve \& covering the entire midface. Application of bilateral suprazygomatic maxillary nerve blockade of the infraorbital nerve may provide effective analgesia for cleft lip repair, improving time to oral intake, pain control and time to hospital discharge.

Research Team

Cameron Smith, MD, PhD

Principal Investigator

University of Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

Efficacy of palatal block for analgesia following palatoplasty in children with cleft palate. [2022]

2. Korea (South) 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. [2019]

3. France pubmed.ncbi.nlm.nih.gov

A new approach for peri-operative analgesia of cleft palate repair in infants: the bilateral suprazygomatic maxillary nerve block. [2022]

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

Effects of preoperative local ropivacaine infiltration on postoperative pain scores in infants and small children undergoing elective cleft palate repair. [2022]

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

Bilateral suprazygomatic maxillary nerve block for cleft palate repair in children: a prospective, randomized, double-blind study versus placebo. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Comparative study of greater palatine nerve block and intravenous pethidine for postoperative analgesia in children undergoing palatoplasty. [2021]

7. United States 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. [2018]

8. France pubmed.ncbi.nlm.nih.gov

Ultrasound guidance characteristics and efficiency of suprazygomatic maxillary nerve blocks in infants: a descriptive prospective study. [2022]

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

Does Sphenopalatine Ganglion Block Improve Pain Control and Intraoperative Hemodynamics in Children Undergoing Palatoplasty? A Randomized Controlled Trial. [2019]