Immediate Post-Operative Anesthesia With Either Lidocaine or Bupivacaine: A Short-term Clinical Response
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Number of Ibuprofen administered
Study Overview
Brief Summary
Immediate post-suturing administration of either one of two dental anesthetic solutions or a placebo prior to dismissal.
Detailed Description
This study seeks to evaluate the pain response following the administration of two anesthetic solutions just prior to patient dismissal from a surgical procedure: 2% Xylocaine with 1:100,000 epi and 0.5% Bupivicaine with 1:200,000 epi in comparison with 0.9% Normal Saline as a placebo. the study team will monitor pain response following these interventions at 4, 8, 12, 24, and 48 hours.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Both the surgeon and patient will be blinded as to the intervention provided by covering identifying marks of the anesthetic carpules to be administered. Randomization will be assured by random selection of a slip of paper drawn from a sealed envelope assigning the patient to one of three groups.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients who have undergone a comprehensive periodontal evaluation and treatment plan not related to participation in this study and...
- •require flap surgery of 2 to 5 teeth in a continuous site (including flap debridement, flap osseous, extractions, and Guided Tissue Regeneration (GTR) procedures), and...
- •require IV sedation and local anesthesia or local anesthesia only...
- •in either the maxillary or mandibular arch.
Exclusion Criteria
- •Pregnancy, or those planning to become pregnant
- •allergy or any medical issue using Lidocaine or Bupivacaine
- •inability to take non-steroidal anti-inflammatory drugs (NSAIDS) or acetaminophen
- •non-English speaking
- •not possessing an I-phone or Android device
- •patients requiring narcotic for IV sedation
- •patients requiring either IV or oral steroids during the perioperative period
Arms & Interventions
Placebo control group
Participants have been scheduled to receive an area of gum surgery to treat periodontal (gum) disease in their mouth while under intravenous (IV) conscious sedation. The study drug is administered after surgery.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Number of Ibuprofen administered
Time Frame: Baseline to 48 hours
Additive number of ibuprofen taken over monitoring period
Change in pain using Visual Analog Scale (VAS)
Time Frame: Baseline to 48 hours
Pain response recorded using a 20 point visual Analog Scale. The VAS scale is a straight line scale scored from 0-20 with 0 indicating the least amount of pain and 20 the worst pain ever experienced.
Number of Tylenol administered
Time Frame: Baseline to 48 hours
Additive number of acetaminophen taken over monitoring period
Secondary Outcomes
- Type of procedure(Baseline to 48 hours)
- Arch Response(Baseline to 48 hours)
- Number of teeth(Baseline to 48 hours)
- Gender of patient(Baseline to 48 hours)
- Age of patient(Baseline to 48 hours)