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Local Anesthetic

Nerve Block for Cleft Palate Pain Control

Phase < 1
Waitlist Available
Led By Cameron R Smith, MD, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient presenting for palatoplasty for cleft palate only
No underlying chronic pain condition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline (post-op) and through study completion, an average of 96 hours.
Awards & highlights

Study Summary

This trial found that nerve blocks may provide more effective pain control for cleft palate repair than opioids, leading to shorter hospital stays.

Who is the study for?
This trial is for children needing surgery to repair a cleft palate, who can eat and drink normally before the operation, and don't have chronic pain conditions. It's not for those needing additional surgeries beyond palatoplasty or with factors that make nerve block placement or research participation risky as judged by the study team.Check my eligibility
What is being tested?
The study tests if blocking nerves near the midface with Ropivacaine provides better post-surgery pain relief compared to a sham treatment. The goal is to see if this method improves recovery time, reduces pain more effectively, and allows quicker return to normal eating which may lead to an earlier hospital discharge.See study design
What are the potential side effects?
Ropivacaine might cause side effects like numbness in areas other than intended, low blood pressure, nausea, vomiting or allergic reactions. Serious complications are rare but could include seizures or heart problems if the drug enters the bloodstream.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having surgery to repair a cleft palate only.
Select...
I do not have a chronic pain condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline (post-op) and through study completion, an average of 96 hours.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (post-op) and through study completion, an average of 96 hours. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in time to oral intake following palatoplasty for cleft palate
Secondary outcome measures
Change in amount of opioids following palatoplasty for cleft palate
Change in length of hospitalization following palatoplasty for cleft palate

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Suprazygomatic maxillary nerve blockadeExperimental Treatment1 Intervention
A single injection into the pterygopalatine fossa bilaterally of 0.2% ropivacaine at a dose of 0.15 mL/kg (block) after the induction of general anesthesia.
Group II: 25 Gauge needlePlacebo Group1 Intervention
Subcutaneous placement of a 25 Gauge needle as a sham comparator after the induction of general anesthesia. Nothing will be injected.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ropivacaine
2017
Completed Phase 4
~1960

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,333 Previous Clinical Trials
714,551 Total Patients Enrolled
2 Trials studying Cleft Palate
475 Patients Enrolled for Cleft Palate
Cameron R Smith, MD, PhDPrincipal InvestigatorUniversity of Florida

Media Library

Ropivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT03632044 — Phase < 1
Cleft Palate Research Study Groups: 25 Gauge needle, Suprazygomatic maxillary nerve blockade
Cleft Palate Clinical Trial 2023: Ropivacaine Highlights & Side Effects. Trial Name: NCT03632044 — Phase < 1
Ropivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03632044 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what scenarios is Ropivacaine typically deployed as a medical treatment?

"When it comes to anesthesia, ropivacaine is a common go-to. This medication can also be utilized for labor pain and postoperative discomfort in addition to its traditional usage of surgical anaesthesia."

Answered by AI

Who is eligible to partake in this clinical trial?

"This experiment is open to 40 infants between 3 months and 5 years afflicted with orofacial deformities. The primary requirements for enrolment are: the presenting condition should be a cleft palate, parental/guardian consent must be obtained, participants need to have been able to consume food/water before surgery, no pre-existing chronic pain disorder."

Answered by AI

Are there any preceding studies involving Ropivacaine that are worth taking into consideration?

"At present, there are 67 live clinical trials examining the efficacy of Ropivacaine. Of those ongoing studies, 15 have reached Phase 3 and span 89 locations - primarily in Karachi, Sindh."

Answered by AI

Are senior citizens eligible for this experiment?

"The guidelines for this medical trial state that participants must be between 3 Months and 5 years of age."

Answered by AI

Are there any openings available within this clinical trial?

"This clinical trial is no longer enrolling participants, as the last update on its data was made on May 23rd 2022. For those interested in other studies, there are currently 126 investigations for mouth abnormalities and 67 trials involving Ropivacaine that need volunteers to take part."

Answered by AI

How many individuals are being recruited as participants in this clinical trial?

"Unfortunately, this clinical trial is no longer seeking candidates. It was initially posted on November 20th 2018 and its last edit occurred on May 23rd 2022. For those looking for other options, 126 studies are actively searching for participants with oral irregularities and 67 trials utilising Ropivacaine have begun accepting patients."

Answered by AI
~2 spots leftby Jun 2024