Clinical trial NCT04909619: Suprazygomatic Maxillary Nerve Block in Cleft Palate Outcomes
Official title: Suprazygomatic Maxillary Nerve Block in Cleft Palate Outcomes: Can we Minimize Analgesic and Opioid Use?
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cleft Palate Children
Keywords: Nerve Block
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 40
Sex: ALL
Minimum age (years): 9
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on postoperative pain scores.
timeFrame: 48 hours after discharge
measure: Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on perioperative analgesia requirements.
timeFrame: 48 hours after discharge
Secondary outcomes:
measure: Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on length of stay.
timeFrame: 48 hours after discharge
measure: Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on time to oral intake.
timeFrame: 48 hours after discharge
measure: Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on total amount of fluids consumed.
timeFrame: 48 hours after discharge
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Arun K Gosain, MD
role: PRINCIPAL_INVESTIGATOR
References: