Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia

University of Nebraska

Status and phase: Terminated; Phase 4

Conditions: Local Anesthesia

Treatments: Drug: lidocaine; Drug: sodium bicarbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT02647892

0787-15-EP

Details and patient eligibility

About

The purpose of this study is to determine the optimal amount of lidocaine buffering needed to decrease injection pain when administering local anesthesia.

Full description

Once the site is chosen, the skin will be anesthetized as usual. This study will utilize a commercially prepared 1% lidocaine solution mixed with standard sodium bicarbonate. A total of 10 mL will be used.

Enrollment: 70 patients

Sex: All

Ages: 19 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adults presenting for routine thyroid biopsy, paracentesis or thoracentesis in interventional radiology

Exclusion criteria

• Patients requiring sedation
• Patients with altered mental status
• Children
• Patients allergic to lidocaine or sodium bicarbonate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 4 patient groups

Arm A

Active Comparator group

Description:

10 mg/mL lidocaine; Frequency: 1

Treatment:

Drug: lidocaine

Arm B

Active Comparator group

Description:

9 mg/mL of 10% sodium bicarbonate-90% lidocaine; Frequency: 1

Treatment:

Drug: lidocaine

Drug: sodium bicarbonate

Arm C

Active Comparator group

Description:

7.5 mg/Ml of 25% sodium bicarbonate-75% lidocaine Frequency: 1

Treatment:

Drug: lidocaine

Drug: sodium bicarbonate

Arm D

Active Comparator group

Description:

5 mg/mL 50% sodium bicarbonate-50% lidocaine Frequency: 1

Treatment:

Drug: lidocaine

Drug: sodium bicarbonate