"Comparison of Buffered Versus Non-Buffered Local Anesthetic in Patients With Inflamed Tissues for Pain Perception, Onset, Duration and Adverse Effects"

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorKing Edward Medical University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Buffered Local Anesthesia

    Drug

    The investigator will add Sodium bicarbonate in lidocaine with adrenaline (1:80,000 ) for Buffered Local anesthesia.

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

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.
2

Onset Time

The duration between the administration of the anesthetic injection and sensation checked by sharp object at the anesthetized site

Time frame
Every 30 seconds up to 1/2 hour

Secondary outcomes

1

Patient satisfaction

Patient satisfaction with pain management post procedure will also be measured on the Scale of 1-5(poor- excellent)

Time frame
Up to 24 hours after the procedure
2

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.

Time frame
Every 30 minutes for up to 4 hours
3

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.

Time frame
every 30 minutes for up to 2 hours
4

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.

Time frame
Every 30seconds for up to 24 hour

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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