Pain Related to Local Anesthetic Administration for Nexplanon Placement

University of California San Diego

Status: Not yet enrolling

Conditions: Pain Related to Local Anesthetic Administration for Nexplanon Placement

Treatments: Combination Product: we will prepare 3cc of buffered lidocaine consisting of 2.7cc of 1% lidocaine and 0.3cc of 8.4% sodium bicarbonate; Other: Unbuffered lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT07008222

812038

Details and patient eligibility

About

This research study is being conducted to see if using buffered lidocaine for Nexplanon placement decreases pain associated with administering local anesthesia compared to unbuffered lidocaine, which is currently used in clinic. Lidocaine is used to stop pain in the nerve fibers in order to decrease pain at the time of the procedure. We want to find out if using buffered lidocaine will decrease discomfort at the time of receiving local anesthesia for Nexplanon insertion.

Enrollment: 68 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ability to provide informed consent
• Women, aged 18-50 who are English or Spanish speaking who present for Nexplanon placement for contraception
• Participants must not have a past medical history of substance use disorders, pain disorders, use of pain medications or are found to be pregnant

Exclusion criteria

• Current use of pain medication prior to procedure
• Diagnosed chronic pain condition
• Pregnancy
• Known allergic reactions to components of the local anesthetic
• History of Nexplanon placement
• Current substance use or history of substance use
• Known contraindications to Nexplanon, such as history of breast cancer, Systemic lupus erythematosus with positive (or unknown) antiphospholipid antibodies, unexplained vaginal bleeding, and liver conditions, including hepatocellular adenoma, malignant liver tumor, and decompensated cirrhosis.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups

Buffered Lidocaine Anesthetic Group

Experimental group

Description:

will prepare 3cc of buffered lidocaine consisting of 2.7cc of 1% lidocaine and 0.3cc of 8.4% sodium bicarbonate

Treatment:

Combination Product: we will prepare 3cc of buffered lidocaine consisting of 2.7cc of 1% lidocaine and 0.3cc of 8.4% sodium bicarbonate

Un-buffered Lidocaine Anesthetic Group

Active Comparator group

Description:

3cc of unbuffered 1% lidocaine

Treatment:

Other: Unbuffered lidocaine