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

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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07592143
Enrollment
68
Registered
2026-05-18
Start date
2026-07-01
Completion date
2026-12-31
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comparison of Buffered Versus Non Buffered Local Anesthetic In Inflamed Tissues

Keywords

Buffered, Non Buffered, Local anesthesia, Inflamed tissues

Brief summary

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

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

Sponsors

King Edward Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain PerceptionPain 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.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 TimeEvery 30 seconds up to 1/2 hourThe duration between the administration of the anesthetic injection and sensation checked by sharp object at the anesthetized site

Secondary

MeasureTime frameDescription
Patient satisfactionUp to 24 hours after the procedurePatient satisfaction with pain management post procedure will also be measured on the Scale of 1-5(poor- excellent)
Duration of ActionEvery 30 minutes for up to 4 hoursThe 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 Effectsevery 30 minutes for up to 2 hoursAdverse 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:Every 30seconds for up to 24 hourThe 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.

Contacts

CONTACTHafiz M Usman
usmanyaqoob319@gmail.com+923327208618
PRINCIPAL_INVESTIGATORHafiz M Usman

King Edward Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026