Evaluation of Trigeminal Nerve Blockade

University of Florida

Status and phase: Active, not recruiting; Phase 4

Conditions: Cleft Palate; Mouth Abnormalities; Birth Defect

Treatments: Other: Sham Comparator; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03632044

OCR18511 (Other Identifier)

IRB201801011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 3 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Suprazygomatic maxillary nerve blockade

Experimental group

Description:

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.

Treatment:

Drug: Ropivacaine

25 Gauge needle

Sham Comparator group

Description:

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

Treatment:

Other: Sham Comparator