Pain Related to Local Anesthetic Administration for Nexplanon Placement

Not Applicable

Not yet recruiting

• Conditions: Pain Related to Local Anesthetic Administration for Nexplanon Placement

• Registration Number: NCT07008222
• Lead Sponsor: University of California, San Diego

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-28
• Study First Submitted QC: 2025-05-28
• Last Update Submitted: 2025-05-28
• Study Start: 2025-06
• Study First Posted: 2025-06-06
• Last Update Posted: 2025-06-06
• Primary Completion: 2026-01
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Magnitude of pain at time of local anesthesia for Nexplanon placement	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 Outcome Measures

Name	Time	Method
Patient satisfaction	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?).
Anticipated pain, prior to anesthetic administration	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.
Baseline pain	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
Pain with Nexplanon placement	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
Pain associated with overall procedure	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.
Overall Nexplanon placement experience	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).
Need for additional pain medication	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.
Participants belief	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).