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OpenTrials
Active, Not Recruiting

NCT Number: NCT03632044

Evaluation of Trigeminal Nerve Blockade

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

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 names: Naropin

Sham Comparator

Other

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

Other names: Control

Primary outcomes

  1. Change in time to oral intake following palatoplasty for cleft palate

    Time frame: 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 outcomes

  1. Change in amount of opioids following palatoplasty for cleft palate

    Time frame: 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.

  2. Change in length of hospitalization following palatoplasty for cleft palate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Aug 15, 2018
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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