SZMN Blocks for Pain Control in Pediatric Patients Undergoing T&A (SZMN)
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| ClinicalTrials.gov Identifier: NCT04797559 |
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Recruitment Status :
Recruiting
First Posted : March 15, 2021
Last Update Posted : December 13, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Postoperative Pain Opioid Use | Procedure: SZaMN Block | Not Applicable |
Patients between 6 months and 18 years undergoing T&A surgical procedures will be reviewed for potential study enrollment. If participants agree to participate, they will be randomized into either the suprazygomatic maxillary nerve (SZaMN) block treatment cohort or the control cohort i.e standard of care.
After anesthesia induction, patients randomized into the SZaMN- treatment group will receive a bilateral single injection SZaMN block under general anesthesia in the operating room. The injection will occur near the temples above the cheek bones.
Participants enrolled into the control group will receive standard of care with no changes to their anesthetic or surgical care. Both groups will be asked for their verbal pain scores in the PACU and we will track their opioid consumption throughout the next few days after their procedure.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Patients in the interventional group will receive a total of 5 mL of local anesthetic bilaterally near their temples. |
| Masking: | Double (Participant, Care Provider) |
| Masking Description: | Both groups will receive a small circular band-aid on their temples. |
| Primary Purpose: | Treatment |
| Official Title: | Suprazygomatic Maxillary Nerve (SZMN) Blocks for Pain Control in Pediatric Patients Undergoing T&A: Randomized Controlled Trial ] |
| Actual Study Start Date : | November 29, 2021 |
| Estimated Primary Completion Date : | July 2022 |
| Estimated Study Completion Date : | July 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: SZaMN Treatment Group
Patients randomized into the SZaMN-treatment group will receive a bilateral single injection SZaMN block under general anesthesia in the operating room. The injection will occur through the pterygomaxillary fissure into the pterygomaxillary fossa. Patients will receive 5 ml of local anesthestic per side.
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Procedure: SZaMN Block
Suprazygomatic Maxillary Nerve (SZaMN) Blocks bilaterally near the temples of the patient |
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No Intervention: Control Group
Patients in this group will receive the standard of care for T&A procedures within the pediatric population.
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- Post Surgical Pain [ Time Frame: 2-3 days after surgery ]Patients will rate their pain on a 0-10 scale
- Opioid Consumption [ Time Frame: 2-3 days after surgery ]Pain medications consumed by patients will be collected
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| Ages Eligible for Study: | 6 Months to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Ages 0-18
- Give consent/parental consent to participate in study
- Patients undergoing tonsillectomy and adenoidectomy
Exclusion Criteria:
- Participants who do not consent or have parental consent
- Patients who are clinically unstable or require urgent/emergent intervention
- Patients under age 6 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04797559
| Contact: Ban CH Tsui, MD | (650) 200-9107 | bantsui@stanford.edu | |
| Contact: Ksenia Kasimova, MD | (650) 788-9458 | kasimova@stanford.edu |
| United States, California | |
| Lucille Packard Children's Hospital | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Ban Tsui, MD 650-200-9107 bantsui@stanford.edu | |
| Study Director: | Ban C Tsui, MD | Professor | |
| Principal Investigator: | Carole Lin, MD | Pediatric Anesthesiologist |
Other Publications:
| Responsible Party: | Chi-Ho Ban Tsui, Professor, Stanford University |
| ClinicalTrials.gov Identifier: | NCT04797559 |
| Other Study ID Numbers: |
60450 |
| First Posted: | March 15, 2021 Key Record Dates |
| Last Update Posted: | December 13, 2021 |
| Last Verified: | November 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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SZaMN Block Tonsillectomy and Adenoidectomy Regional Anesthesia |
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Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations |