Clinical Study to Evaluate the Effect of pH on Pain Upon Local Anesthetic Administration.

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Brian Wainger, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01304082
First received: February 18, 2011
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

When one receives a local anesthetic, such as novocaine for a dental procedure, there is a burning painful sensation experienced upon injection of the local anesthetic. We are trying to understand the role of pH (how acidic a solution is) in the production of pain during local anesthetic administration. We hypothesize that less acidic solutions produce less burning. We also want to determine whether or not the pH of the solution affects the rate of onset of the local anesthesia. We will recruit subjects from patients who have a clinical indication for lumbar medial branch (LMB) nerve blocks, procedures frequently performed at the Massachusetts General Hospital Center for Pain Medicine. For each patient, three nerve blocks are administered at adjacent spinal levels, typically using either lidocaine or bicarbonate-buffered lidocaine as the local anesthetic. We will add a saline control as part of the research procedure and then provide lidocaine at the control location before continuing with the nerve blocks. This clinical procedure offers an ideal opportunity to compare the effects of the three solutions. There will be almost no deviation from the standard clinical procedure. After the injection of each solution, the pain score on administration of the medication will be recorded immediately. We will also provide a continuous stimulation (pin taps) after the local anesthetic injection and record when the patient experiences hypoesthesia (reduced sensation) and anesthesia (absent sensation). Finally, we will record the pain score upon reinsertion of a needle to mark the precise location (part of the clinical procedure) one minute after the local anesthetic injection. All data will be collected during the a single clinical visit.

The study will conclude when 60 subjects have successfully been tested. Data will be reviewed annually.


Condition Intervention
Local Anesthetics
Drug: Lidocaine
Drug: normal saline
Drug: alkalinized lidocaine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
Official Title: A Single-center, Randomized, Double-blind Clinical Study to Evaluate the Effect of pH on Pain Upon Local Anesthetic Administration.

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • pain score [ Time Frame: immediate, upon injection of each solution ] [ Designated as safety issue: No ]
    Pain score upon injection of local anesthetic


Secondary Outcome Measures:
  • time until hypoesthesia [ Time Frame: 0-180 seconds after each injection. ] [ Designated as safety issue: No ]
    time until hypoesthesia will be assessed using a sensory stimulus

  • time until anesthesia [ Time Frame: 0-180 seconds after each injection ] [ Designated as safety issue: No ]
    Time until anesthesia will be assessed using a repeated sensory stimulus.

  • pain score upon needle stick. [ Time Frame: 1 minute after each injection ] [ Designated as safety issue: No ]
    Pain score upon needle stick.


Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: normal saline Drug: normal saline
1 ml subcutaneous injection 0.9% sodium chloride, given once
Active Comparator: lidocaine Drug: Lidocaine
1 ml subcutaneous injection of 0.9% lidocaine, given once
Experimental: alkalinized lidocaine Drug: alkalinized lidocaine
1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients at MGH Center for Pain Medicine who have clinical indication for undergoing diagnostic medial branch block of nerves to facet joints.

Exclusion Criteria:

  • contraindication to the clinical procedure
  • do not speak English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304082

Contacts
Contact: Brian Wainger, MD, PhD 617 726-8810 bwainger@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Brian J Wainger, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Brian Wainger, Instructor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01304082     History of Changes
Other Study ID Numbers: 2010-P-000533
Study First Received: February 18, 2011
Last Updated: December 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
pain pH local anesthetics

Additional relevant MeSH terms:
Anesthetics, Local
Lidocaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014