Birth Defect, Cleft Palate, Mouth Abnormalities
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGRopivacaine
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
OTHERSham Comparator
The subcutaneous placement of a 25 Gauge needle as a sham control after the induction of general anesthesia. Nothing will be injected.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
During the block placement the surgical team will be asked to leave the operating room briefly to remain blinded to the group assignment of all patients as the surgical team will manage the subjects post-operative care and determine discharge readiness. ICU nursing staff and parents will be informed of participation in the study but will not be informed as to group assignment to remain blinded.
Intervention model description
This randomized, double-blinded study. Subjects will be randomly assigned to one of two different protocols by a designated study team member based on a computer generated randomization table. Randomization will occur following consent. Randomization will be 1:1.
Eligibility
Sex/Gender
ALL
Age
3 Months to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in time to oral intake following palatoplasty for cleft palate | Change from baseline (post-op) and through study completion, an average of 96 hours. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in amount of opioids following palatoplasty for cleft palate | Change from baseline (post-op) and through study completion, an average of 96 hours. | 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 in length of hospitalization following palatoplasty for cleft palate | Change from baseline (post-op) and through study completion, an average of 96 hours. | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCameron R Smith, MD, PhD
University of Florida
Outcome results
None listed