Pain Related to Local Anesthetic Administration for Nexplanon Placement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2026-02-28

Brief Summary

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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.

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Pain

COMPLETED PHASE4

Detailed Description

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Conditions

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Pain Related to Local Anesthetic Administration for Nexplanon Placement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The participant and clinician will be blinded to their randomization. The group assignment will be in a sealed envelope opened by the clinic nurse and administered by the clinician. The envelopes will previously have been filled with group assignments (buffered vs nonbuffered lidocaine groups) and will then be shuffled prior to in-clinic use to determine participant group assignment.

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Buffered Lidocaine Anesthetic Group

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

Group Type EXPERIMENTAL

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

Intervention Type COMBINATION_PRODUCT

Either 3cc of unbuffered lidocaine (control) or 3cc of buffered 1% lidocaine (intervention) will be prepared and administered by the clinician. In a study investigating buffered lidocaine versus unbuffered lidocaine in intrauterine device insertion, investigators prepared 20cc of buffered lidocaine utilizing 18cc of 1% lidocaine (90%) and 2cc of 8.4% sodium bicarbonate (10%). 3 Thus, 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

3cc of unbuffered 1% lidocaine

Group Type ACTIVE_COMPARATOR

Unbuffered lidocaine

Intervention Type OTHER

For the control, 3cc of unbuffered lidocaine will be prepared and administered by the clinician.

Interventions

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

Either 3cc of unbuffered lidocaine (control) or 3cc of buffered 1% lidocaine (intervention) will be prepared and administered by the clinician. In a study investigating buffered lidocaine versus unbuffered lidocaine in intrauterine device insertion, investigators prepared 20cc of buffered lidocaine utilizing 18cc of 1% lidocaine (90%) and 2cc of 8.4% sodium bicarbonate (10%). 3 Thus, we will prepare 3cc of buffered lidocaine consisting of 2.7cc of 1% lidocaine and 0.3cc of 8.4% sodium bicarbonate.

Intervention Type COMBINATION_PRODUCT

Unbuffered lidocaine

For the control, 3cc of unbuffered lidocaine will be prepared and administered by the clinician.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes