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Suprazygomatic Maxillary Nerve Block in Cleft Palate Outcomes

Primary Purpose

Cleft Palate Children

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound-guided bilateral suprazygomatic maxillary nerve block
Local anesthetic infiltration of the palate
Sponsored by
Ann & Robert H Lurie Children's Hospital of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Palate Children focused on measuring Nerve Block

Eligibility Criteria

9 Months - 2 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ann & Robert H. Lurie Children's Hospital of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasound-guided bilateral suprazygomatic maxillary nerve block

Local anesthetic infiltration of the palate

Arm Description

Patients randomized to this arm will receive an ultrasound-guided bilateral suprazygomatic maxillary nerve block using 0.15 ml/kg of 0.2% ropivacaine per side, for a total of 0.3 ml/kg immediately after induction of general anesthesia and prior to incision. Participants will also receive local infiltration of the palate with an equivalent injection volume of 0.9% saline with 1:400,000 epinephrine at 2 ml/kg. Pediatric anesthesiologists with fellowship training in regional anesthesia will perform the nerve block. Local anesthetic infiltration will be performed by one of four board-certified pediatric plastic and craniofacial surgeons during repair of the palate. Patients, parents, surgeons, and the anesthesiologist will not be blinded to the specific intervention group due to the nature of the procedures involved. Nurses and the two key personnel responsible for data collection and analysis will be blinded throughout the entirety of the study.

Patients randomized to this arm will receive local infiltration of the palate using 0.125% bupivacaine + 1:400,000 epinephrine at a dose of 2 ml/kg intraoperatively. Local anesthetic infiltration will be performed by one of four board-certified pediatric plastic and craniofacial surgeons during repair of the palate. Patients, parents, surgeons, and the anesthesiologist will not be blinded to the specific intervention group due to the nature of the procedures involved. Nurses and the two key personnel responsible for data collection and analysis will be blinded throughout the entirety of the study.

Outcomes

Primary Outcome Measures

Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on postoperative pain scores.
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.
The primary outcome for this aim will be perioperative opioid consumption reported in morphine milligram equivalents.

Secondary Outcome Measures

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

Full Information

First Posted
March 12, 2021
Last Updated
July 6, 2021
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT04909619
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Palate Children
Keywords
Nerve Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound-guided bilateral suprazygomatic maxillary nerve block
Arm Type
Experimental
Arm Description
Patients randomized to this arm will receive an ultrasound-guided bilateral suprazygomatic maxillary nerve block using 0.15 ml/kg of 0.2% ropivacaine per side, for a total of 0.3 ml/kg immediately after induction of general anesthesia and prior to incision. Participants will also receive local infiltration of the palate with an equivalent injection volume of 0.9% saline with 1:400,000 epinephrine at 2 ml/kg. Pediatric anesthesiologists with fellowship training in regional anesthesia will perform the nerve block. Local anesthetic infiltration will be performed by one of four board-certified pediatric plastic and craniofacial surgeons during repair of the palate. Patients, parents, surgeons, and the anesthesiologist will not be blinded to the specific intervention group due to the nature of the procedures involved. Nurses and the two key personnel responsible for data collection and analysis will be blinded throughout the entirety of the study.
Arm Title
Local anesthetic infiltration of the palate
Arm Type
Active Comparator
Arm Description
Patients randomized to this arm will receive local infiltration of the palate using 0.125% bupivacaine + 1:400,000 epinephrine at a dose of 2 ml/kg intraoperatively. Local anesthetic infiltration will be performed by one of four board-certified pediatric plastic and craniofacial surgeons during repair of the palate. Patients, parents, surgeons, and the anesthesiologist will not be blinded to the specific intervention group due to the nature of the procedures involved. Nurses and the two key personnel responsible for data collection and analysis will be blinded throughout the entirety of the study.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided bilateral suprazygomatic maxillary nerve block
Intervention Description
The maxillary nerve, V2, is purely a sensory branch of the trigeminal nerve. V2 exits the skull through the foramen rotundum and courses through the pterygopalatine fossa, a small pyramid-shaped depression located posterior to the maxilla. As the maxillary nerve exits the pterygopalatine fossa, it divides into numerous branches that supply sensation to the posterior nasal cavity, palate, sinuses, and maxilla. It is within the pterygopalatine fossa that the maxillary nerve is targeted and anesthetized during the block. With the patient in the supine position after nasotracheal intubation, a needle is inserted perpendicularly between the upper border of the zygomatic arch and posterior orbital rim until it reaches the greater wing of the sphenoid, where the needle is then retracted by a few millimeters and redirected toward the nasolabial fold until it hits the pterygopalatine fossa.
Intervention Type
Procedure
Intervention Name(s)
Local anesthetic infiltration of the palate
Intervention Description
Local anesthetic infiltration of the palate during cleft palate repair is universally practiced. The benefits of local anesthetic infiltration are twofold: to provide anesthesia to the terminal branches of the nasopalatine and greater palatine nerves that are in the immediate area of the injection sites and to achieve hemostasis during closure when the medication is mixed with epinephrine. To administer local anesthetic infiltration of the palate, a 25 gauge needle is inserted next to the incision into the soft tissue. The tissue is first aspirated to determine safety of injection at that site. The medication is then injected parallel to the incision on both sides.
Primary Outcome Measure Information:
Title
Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on postoperative pain scores.
Description
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.
Time Frame
48 hours after discharge
Title
Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on perioperative analgesia requirements.
Description
The primary outcome for this aim will be perioperative opioid consumption reported in morphine milligram equivalents.
Time Frame
48 hours after discharge
Secondary Outcome Measure Information:
Title
Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on length of stay.
Description
A blinded researcher will perform a thorough review of patient data to determine the duration of hospital stay (hours).
Time Frame
48 hours after discharge
Title
Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on time to oral intake.
Description
A blinded researcher will perform a thorough review of patient data to determine the time to oral intake (minutes).
Time Frame
48 hours after discharge
Title
Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on total amount of fluids consumed.
Description
A blinded researcher will perform a thorough review of patient data to determine the total amount of fluids consumed (ounces).
Time Frame
48 hours after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arun K Gosain, MD
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Suprazygomatic Maxillary Nerve Block in Cleft Palate Outcomes

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