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

NCT07592143 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 631/RC/KEMU
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Comparison of Buffered Versus Non Buffered Local Anesthetic In Inflamed Tissues

Keywords

Buffered; Non Buffered; Local anesthesia; Inflamed tissues

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Patient satisfaction

  Up to 24 hours after the procedure

• Duration of Action

  Every 30 minutes for up to 4 hours

• Adverse Effects

  every 30 minutes for up to 2 hours

• Co-morbid conditions:

  Every 30seconds for up to 24 hour

Study Arms (2)

Group A

EXPERIMENTAL

Group A will get Buffered Local Anesthesia

Drug: Buffered Local Anesthesia

Group B

NO INTERVENTION

Group B will get Non-Buffered local anesthesia

Interventions

Buffered Local Anesthesia DRUG

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

Group A

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient age between 18 and 60 and all gender.
• Patients requiring surgical wound debridement under local anesthesia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Edward Medical University: lead

Study Officials

• Hafiz M Usman

  King Edward Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hafiz M Usman

CONTACT

+923327208618; usmanyaqoob319@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share