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

NCT01304082 | Terminated Results DMC

• 1 other identifier: 2010-P-000533
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Local Anesthetics

Keywords

pain pH local anesthetics

Outcome Measures

Primary Outcomes (1)

• Rank-transformed Pain Score

  Pain score upon injection of local anesthetic: the pain score is a validated 11-point numeric rating scale in which patients rate pain between 0 (no pain) and 10 (worst pain imaginable).

  immediate, upon injection of each solution

Secondary Outcomes (3)

• Rank-transformed Time (Seconds) Until Hypoesthesia

  0-180 seconds after each injection.

• Rank-transformed Time (Seconds) Until Anesthesia

  0-180 seconds after each injection

• Rank-transformed Pain Score Upon Needle Stick.

  1 minute after each injection

Study Arms (3)

normal saline

PLACEBO COMPARATOR

Drug: normal saline

lidocaine

ACTIVE COMPARATOR

Drug: Lidocaine

alkalinized lidocaine

EXPERIMENTAL

Drug: alkalinized lidocaine

Interventions

Lidocaine DRUG

1 ml subcutaneous injection of 0.9% lidocaine, given once

lidocaine

normal saline DRUG

1 ml subcutaneous injection 0.9% sodium chloride, given once

normal saline

alkalinized lidocaine DRUG

1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate

alkalinized lidocaine

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• contraindication to the clinical procedure
• do not speak English

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Lidocaine; Saline Solution

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Brian Wainger
• Organization: Massachusetts General Hospital

bwainger@partners.org

617-726-8810

Study Officials

• Brian J Wainger, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 25, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 11, 2017
• Results First Posted: April 11, 2017

Record last verified: 2017-02

Locations

US (1)