Suprazygomatic Maxillary Nerve Block in Cleft Palate Outcomes

Not Applicable

• Conditions: Cleft Palate Children

• Registration Number: NCT04909619
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary

Increased pain after cleft palate surgery is the leading cause of increased hospital length of stay, delayed oral intake, readmission, and respiratory compromise. The goal is to improve all outcomes by identifying the most effective evidenced-based method of intra-operative pain control.

Detailed Description

Cleft palate repair is associated with significant perioperative pain that may require increased depth of anesthesia intraoperatively and can interfere with oral intake and accentuate breathing difficulties postoperatively, resulting in increased length of hospital stay. Optimizing pain control in the perioperative period is essential to best practice for cleft palate repair. Infiltration of the palate with local anesthetic has long been the established mechanism for pain control to minimize intraoperative anesthetic requirement and postoperative opioid use. Suprazygomatic maxillary nerve block (SMB) administered immediately prior to cleft palate repair by anesthesiologists with fellowship training in regional anesthesia is an emerging technique for local anesthetic infiltration. The latter technique is thought to provide superior pain control due to its precise and targeted action on the nerves that innervate the palate, and because it is felt that duration of action may also be prolonged due to specific infiltration around these nerves as opposed to generalized infiltration in the palatal soft tissues. The goal of our study is to evaluate outcomes following the two routes for anesthetic infiltration during cleft palate repair. If either technique is found to be more effective or of greater duration, this can have direct impact in decreasing the need for perioperative opioid use, decreasing hospital length of stay, and less potential for airway suppression from excessive use of postoperative analgesics.

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-03-12
• Study First Submitted QC: 2021-05-26
• Study First Posted: 2021-06-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• All patients undergoing primary cleft palate repair at Ann & Robert H. Lurie Children's Hospital of Chicago during the enrollment period. The typical child at the time of cleft palate repair is age 11 to 12 months.

Exclusion Criteria

• Children with a known allergy to local anesthesia (i.e., ropivacaine or bupivacaine).
• Children with prior surgical repair of the palate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on postoperative pain scores.	48 hours after discharge	The primary outcome for this aim will be pain scores, as determined by the Face, Legs, Activity, Crying, and Consolability scale. Minimum value is 0, maximum value is 10. Higher scores indicate more pain and therefore a worse outcome.
Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on perioperative analgesia requirements.	48 hours after discharge	The primary outcome for this aim will be perioperative opioid consumption reported in morphine milligram equivalents.

Secondary Outcome Measures

Name	Time	Method
Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on total amount of fluids consumed.	48 hours after discharge	A blinded researcher will perform a thorough review of patient data to determine the total amount of fluids consumed (ounces).
Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on length of stay.	48 hours after discharge	A blinded researcher will perform a thorough review of patient data to determine the duration of hospital stay (hours).
Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on time to oral intake.	48 hours after discharge	A blinded researcher will perform a thorough review of patient data to determine the time to oral intake (minutes).

Trial Locations

Locations (1)

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States