Evaluation of Trigeminal Nerve Blockade

Cleft Palate Clinical Trial

Official title:

Evaluation of Trigeminal Nerve Blockade in the Pterygopalatine Fossa for Cleft Palate Repair: a Pilot Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03632044
• Other study ID #: IRB201801011
• Secondary ID: OCR18511
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: November 20, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Cleft palate is a common congenital anomaly for which surgical repair is indicated during early childhood. The surgical repair of cleft palate is very painful, and generally requires high doses of opioids for adequate pain control, placing children at risk for post-operative respiratory depression and airway obstruction. An alternative approach to post-operative analgesia for cleft palate repair is the placement of nerve blocks in the pterygopalatine fossa bilaterally, blocking the maxillary nerve and covering the entire mid-face. This randomized, double-blinded study will investigate the utility of maxillary nerve blockade in controlling post-operative pain, decreasing opioid requirements, improving post-operative oral food and drink intake, and decreasing hospital length-of-stay after cleft palate repair.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 5 Years

Eligibility

Inclusion Criteria:

• Patient presenting for palatoplasty for cleft palate only.

• Parent/guardian consents to participate

• Normal oral food and water intake before surgery

• No underlying chronic pain condition

Exclusion Criteria:

• Parent/guardian refuses to consent

• Patient requires revision surgery on the palate

• Patient requires surgery in addition to palatoplasty, including, but not limited to pharyngeal flap or soft palate lengthening procedures.

• Any underlying chronic pain condition

• Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for block placement.

• Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for research participation.

• History of Pierre Robin sequence

• Planned or anticipated need for any type of artificial airway post-op

Related Conditions & MeSH terms

• Birth Defect
• Cleft Palate
• Congenital Abnormalities
• Mouth Abnormalities

Intervention

Drug:
• Ropivacaine
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

Other:
• Sham Comparator
The subcutaneous placement of a 25 Gauge needle as a sham control after the induction of general anesthesia. Nothing will be injected.

Locations

Country	Name	City	State
United States	UF Health	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in time to oral intake following palatoplasty for cleft palate	Application of bilateral suprazygomatic maxillary nerve blockade of the infraorbital nerve to provide effective analgesia for cleft lip repair, improving time to oral intake after surgery.	Change from baseline (post-op) and through study completion, an average of 96 hours.
Secondary	Change in amount of opioids following palatoplasty for cleft palate	Application of bilateral suprazygomatic maxillary nerve blockade of the infraorbital nerve to provide effective analgesia for cleft lip repair, improving pain control after surgery.	Change from baseline (post-op) and through study completion, an average of 96 hours.
Secondary	Change in length of hospitalization following palatoplasty for cleft palate	Application of bilateral suprazygomatic maxillary nerve blockade of the infraorbital nerve to provide effective analgesia for cleft lip repair, improving time to hospital discharge after surgery.	Change from baseline (post-op) and through study completion, an average of 96 hours.