An interventional study of Palatal Nerve Block and Suprazygomatic Maxillary Nerve Block in Cleft Lip, Cleft Palate +/- Lip and Pain Management, sponsored by Children's National Research Institute. Not yet recruiting. Open to participants aged 9 Months and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Children's National Research Institute · Not applicable, Interventional, and Prevention
This study will evaluate whether adding a suprazygomatic maxillary nerve block to the standard palatal nerve block improves pain control after cleft palate repair surgery in children. Participants will be randomly assigned to receive either the standard palatal block alone or the standard palatal block combined with a suprazygomatic maxillary nerve block. Both techniques use medications commonly used for pain management during surgery.
The purpose of this study is to determine whether the addition of the suprazygomatic maxillary nerve block reduces postoperative pain, decreases the need for opioid medications, and improves recovery after cleft palate repair. Researchers will compare pain scores, medication use, recovery outcomes, and any treatment-related complications between the two groups.
Information collected from this study may help identify the most effective regional anesthesia approach for children undergoing cleft palate repair and may improve postoperative pain management and patient recovery.
167 studies on the registry are indexed under Cleft Lip; 53 are open to participants now.
This study's planned enrollment of 144 is above the median of 30 across 117 interventional studies indexed under Cleft Lip.
Browse Cleft Lip studies →Children's National Research Institute is the lead sponsor of 127 studies on the registry; 47 are open to participants now.
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Exclusion Criteria:
Participants receive the standard palatal nerve block performed during cleft palate surgery.
Procedure: Palatal Nerve Block
Participants receive the standard palatal nerve block plus a suprazygomatic maxillary nerve block during cleft palate surgery.
Procedure: Suprazygomatic Maxillary Nerve Block
Regional anesthetic block of the palate performed during cleft palate or velopharyngeal insufficiency surgery using local anesthetic. This procedure serves as the standard pain management approach and is intended to provide perioperative analgesia and reduce postoperative pain.
Regional anesthetic block of the maxillary nerve performed via a suprazygomatic approach using local anesthetic in addition to the standard palatal nerve block. The procedure is intended to enhance perioperative analgesia, decrease postoperative pain, and reduce postoperative opioid requirements following cleft palate or velopharyngeal insufficiency surgery.
Postoperative Pain Scores
Postoperative pain will be assessed using age-appropriate validated pain scales following cleft palate repair or velopharyngeal insufficiency surgery. Pain scores will be compared between participants receiving a standard palatal nerve block and those receiving a standard palatal nerve block plus a suprazygomatic maxillary nerve block to evaluate the effectiveness of the additional regional anesthesia technique.
Time frame: Within the first 24 hours following surgery
Postoperative Opioid Consumption
Total postoperative opioid medication use will be recorded and compared between participants receiving a standard palatal nerve block and those receiving a standard palatal nerve block plus a suprazygomatic maxillary nerve block. This outcome will assess whether the additional regional anesthesia technique reduces the need for opioid analgesics following surgery.
Time frame: Within the first 24 hours following surgery
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared with researchers outside of the study team. Data collected for this study contain protected health information and were obtained under informed consent and institutional review board requirements that do not include plans for external sharing of individual participant-level data.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.
Of 60 non-industry interventional studies with no phase under Cleft Lip, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 36. This study's planned 12 months is below that.
Counting every sponsor, half of 61 studies reached it within 23 months; a quarter within 17 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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