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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01304082
Other study ID # 2010-P-000533
Secondary ID
Status Recruiting
Phase N/A
First received February 18, 2011
Last updated December 16, 2013
Start date January 2011
Est. completion date February 2015

Study information

Verified date December 2013
Source Massachusetts General Hospital
Contact Brian Wainger, MD, PhD
Phone 617 726-8810
Email bwainger@partners.org
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
Lidocaine
1 ml subcutaneous injection of 0.9% lidocaine, given once
normal saline
1 ml subcutaneous injection 0.9% sodium chloride, given once
alkalinized lidocaine
1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary pain score Pain score upon injection of local anesthetic immediate, upon injection of each solution No
Secondary time until hypoesthesia time until hypoesthesia will be assessed using a sensory stimulus 0-180 seconds after each injection. No
Secondary time until anesthesia Time until anesthesia will be assessed using a repeated sensory stimulus. 0-180 seconds after each injection No
Secondary pain score upon needle stick. Pain score upon needle stick. 1 minute after each injection No
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