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

Local Anesthetics Clinical Trial

Official title:

A Single-center, Randomized, Double-blind Clinical Study to Evaluate the Effect of pH on Pain Upon Local Anesthetic Administration.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01304082
• Other study ID #: 2010-P-000533
• 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

• Local Anesthetics

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