"Comparison of Buffered Versus Non-Buffered Local Anesthetic in Patients With Inflamed Tissues for Pain Perception, Onset, Duration and Adverse Effects"
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Buffered Local Anesthesia.
- Who it may be relevant to
- Registry conditions: Comparison of Buffered Versus Non Buffered Local Anesthetic In Inflamed Tissues. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Buffered Local Anesthesia
The investigator will add Sodium bicarbonate in lidocaine with adrenaline (1:80,000 ) for Buffered Local anesthesia.
Primary outcome measures
- Pain Perception [Time frame: Pain during infiltration will be evaluated at 0 minutes and again at 5 minutes post-infiltration at the onset of surgical procedure and scores will be also taken at 10-minute intervals during the procedure.]
- Onset Time [Time frame: Every 30 seconds up to 1/2 hour]
Secondary outcome measures (4)
- Patient satisfaction [Time frame: Up to 24 hours after the procedure]
- Duration of Action [Time frame: Every 30 minutes for up to 4 hours]
- Adverse Effects [Time frame: every 30 minutes for up to 2 hours]
- Co-morbid conditions: [Time frame: Every 30seconds for up to 24 hour]
Eligibility criteria
Inclusion criteria
- Patient age between 18 and 60 and all gender.
- Patients requiring surgical wound debridement under local anesthesia.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07592143 · 631/RC/KEMU