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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Comparison of Buffered Versus Non Buffered Local Anesthetic In Inflamed Tissues
• Intervention / Treatment: Drug: Buffered Local Anesthesia

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Hafiz M Usman; Phone Number: +923327208618; Email: usmanyaqoob319@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Group A will get Buffered Local Anesthesia	Drug: Buffered Local Anesthesia; The investigator will add Sodium bicarbonate in lidocaine with adrenaline (1:80,000 ) for Buffered Local anesthesia.
No Intervention: Group B; Group B will get Non-Buffered local anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	The duration between the administration of the anesthetic injection and sensation checked by sharp object at the anesthetized site	Every 30 seconds up to 1/2 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patient satisfaction with pain management post procedure will also be measured on the Scale of 1-5(poor- excellent)	Up to 24 hours after the procedure
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.	Every 30 minutes for up to 4 hours
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.	every 30 minutes for up to 2 hours
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.	Every 30seconds for up to 24 hour

Collaborators and Investigators

• Sponsor: King Edward Medical University
• Investigators: Principal Investigator: Hafiz M Usman, King Edward Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Local anesthesia; Buffered; Non Buffered; Inflamed tissues
• Other Study ID Numbers: 631/RC/KEMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No