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NCT Number: NCT07592143

"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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Buffered Local Anesthesia

Drug

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

Primary outcomes

  1. 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.

    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.

  2. Onset Time

    Time frame: Every 30 seconds up to 1/2 hour

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

Secondary outcomes

  1. Patient satisfaction

    Time frame: Up to 24 hours after the procedure

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

  2. Duration of Action

    Time frame: Every 30 minutes for up to 4 hours

    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.

  3. Adverse Effects

    Time frame: every 30 minutes for up to 2 hours

    Adverse effects will also be evaluated carefully during the operative procedure and again at 30 minutes, 1 hour, and 2 hours after the operation.

  4. Co-morbid conditions:

    Time frame: Every 30seconds for up to 24 hour

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hafiz M Usman

CONTACT

[email protected]

+923327208618

Sponsors and collaborators

Lead sponsor

King Edward Medical University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.