About this trial
This study aims to determine whether buffered or non-buffered local anesthetic (LA) is more effective and safer for managing pain in patients with inflamed tissues undergoing surgical procedures. Local anesthetics are widely used to reduce pain, but their effectiveness may vary, particularly in inflamed tissues where achieving adequate anesthesia can be challenging.
In this study, patients will be divided into two groups: one group will receive buffered local anesthetic, and the other will receive non-buffered local anesthetic. The study will compare the level of pain experienced during injection and the procedure, how quickly the anesthetic takes effect, and how long the numbness lasts. In addition, any side effects such as dizziness, nausea, vomiting, allergic reactions, or heart-related complications will be carefully monitored.
The study will also examine whether the presence of co-morbid conditions (such as diabetes, hypertension, or other chronic illnesses) affects the outcomes of both types of anesthetics.
The main question this study seeks to answer is whether buffered local anesthetic provides better pain relief, faster onset, longer duration, and fewer side effects compared to non-buffered local anesthetic, and how these outcomes differ in patients with and without co-morbid conditions. The findings may help improve pain management practices and guide healthcare providers in selecting the most appropriate anesthetic for different patient groups.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient age between 18 and 60 and all gender.
Patients requiring surgical wound debridement under local anesthesia.
Disqualifiers
Pregnant women (documented on medical record).
Patients taking the medications such as narcotics, antidepressants and sedatives from last 3 months that can influence the anesthetic assessment.
Patients with known allergy to local anesthetics or sulfites documented on previous medical record.
Trial design
Parallel
Treatments tested in this trial
Buffered Local Anesthesia
DrugThe investigator will add Sodium bicarbonate in lidocaine with adrenaline (1:80,000 ) for Buffered Local anesthesia.
Treatment groups
Trial outcomes
Primary outcomes
Pain Perception
The level of pain relief achieved by buffered and non-buffered LA will be measured by using Visual Analog Scale from 0 to 10. The highest score thats is 10 represent the Worst pain, the worst outcome and the minimum score that is 0 represents no pain, desirable outcome.
Onset Time
The duration between the administration of the anesthetic injection and sensation checked by sharp object at the anesthetized site
Secondary outcomes
Patient satisfaction
Patient satisfaction with pain management post procedure will also be measured on the Scale of 1-5(poor- excellent)
Duration of Action
The duration of anesthesia will be measured through sensory testing and patient evaluation after every 30 minutes for up to 4 hours until the sensation returns.
Adverse Effects
Adverse effects will also be evaluated carefully during the operative procedure and again at 30 minutes, 1 hour, and 2 hours after the operation.
Co-morbid conditions:
The participants in the control group and study group will be stratified based on the predefined co-morbid conditions documented in their medical records such as DM, HTN, IHD, asthma and renal failure. This stratification will allow the subgroup analyses of the outcome variables of the buffered and non buffered local anesthetic across different clinical profile.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: