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NCT Number: NCT07008222

Pain Related to Local Anesthetic Administration for Nexplanon Placement

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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Key information

Conditions

Pain Related to Local Anesthetic Administration for Nexplanon Placement

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Unbuffered lidocaine

Other

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

Primary outcomes

  1. Magnitude of pain at time of local anesthesia for Nexplanon placement

    Time frame: Will assess pain immediately upon completion of the respective step (i.e. at completion of administration of local anesthetic)

    Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) recorded at the time of local anesthetic administration for Nexplanon placement

Secondary outcomes

  1. Anticipated pain, prior to anesthetic administration

    Time frame: Will assess anticipated pain immediately prior to anesthetic administration

    Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) to describe pain anticipated during procedure prior to anesthetic administration.

  2. Baseline pain

    Time frame: At one point in time occurring at some point from the time of enrollment but prior to Nexplanon placement procedure

    Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) to describe pain at baseline

  3. Pain with Nexplanon placement

    Time frame: Will assess pain associated with Nexplanon placement immediately upon completion of this step

    Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) to describe pain experienced specifically with placement of the Nexplanon

  4. Pain associated with overall procedure

    Time frame: Will assess pain associated with overall procedure immediately following conclusion of Nexplanon placement procedure

    Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) to describe pain associated with the overall Nexplanon placement procedure.

  5. Patient satisfaction

    Time frame: Following completion of Nexplanon placement procedure but prior to conclusion of the procedural visit.

    Will assess participant satisfaction with pain control associated with Nexplanon placement using a Likert scale. We will utilize questions such as "How did the pain with Nexplanon placement compare to the expected pain?", "Would you choose the same pain control method for future implant insertion? and assessing if participant would recommend to a friend (Would you recommend this pain control method to a friend for Nexplanon placement?).

  6. Overall Nexplanon placement experience

    Time frame: Upon completion of Nexplanon placement procedure but prior to conclusion of procedural visit.

    We will assess patient satisfaction with the overall Nexplanon placement experience utilizing VAS scale (anchors 0 mm = not, 100 mm = extremely satisfied).

  7. Need for additional pain medication

    Time frame: Upon completion of Nexplanon placement procedure but prior to conclusion of procedural visit.

    We will assess need for additional pain medication by assessing whether participants require/request additional pain medication (e.g. Tylenol or ibuprofen) prior to completion of their procedural visit.

  8. Participants belief

    Time frame: Upon completion of Nexplanon placement but prior to conclusion of the procedural visit.

    We will assess participants belief regarding if they were in the intervention or control group (i.e. whether they received buffered versus unbuffered lidocaine for local anesthetic prior to Nexplanon placement).

Study contacts

Contact information is provided by the study sponsor or research team.

McKensie M Wall, MD, MPH

CONTACT

[email protected]

858-249-1206

Sheila Mody, MD, MPH

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Pain Related to Local Anesthetic Administration for Nexplanon Placement: A Randomized Control Trial of Buffered Lidocaine

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.