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

NCT ID: NCT01304082

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2014-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

normal saline

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

1 ml subcutaneous injection 0.9% sodium chloride, given once

lidocaine

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

1 ml subcutaneous injection of 0.9% lidocaine, given once

alkalinized lidocaine

Group Type: EXPERIMENTAL

alkalinized lidocaine

Intervention Type: DRUG

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

Interventions

Lidocaine

1 ml subcutaneous injection of 0.9% lidocaine, given once

Intervention Type: DRUG

normal saline

1 ml subcutaneous injection 0.9% sodium chloride, given once

Intervention Type: DRUG

alkalinized lidocaine

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Brian Wainger

Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian J Wainger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2010-P-000533

Identifier Type: -

Identifier Source: org_study_id