Clinical trial NCT07008222: Pain Related to Local Anesthetic Administration for Nexplanon Placement
Official title: Pain Related to Local Anesthetic Administration for Nexplanon Placement: A Randomized Control Trial of Buffered Lidocaine
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain Related to Local Anesthetic Administration for Nexplanon Placement
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Magnitude of pain at time of local anesthesia for Nexplanon placement
timeFrame: Will assess pain immediately upon completion of the respective step (i.e. at completion of administration of local anesthetic)
Secondary outcomes:
measure: Anticipated pain, prior to anesthetic administration
timeFrame: Will assess anticipated pain immediately prior to anesthetic administration
measure: Baseline pain
timeFrame: At one point in time occurring at some point from the time of enrollment but prior to Nexplanon placement procedure
measure: Pain with Nexplanon placement
timeFrame: Will assess pain associated with Nexplanon placement immediately upon completion of this step
measure: Pain associated with overall procedure
timeFrame: Will assess pain associated with overall procedure immediately following conclusion of Nexplanon placement procedure
measure: Patient satisfaction
timeFrame: Following completion of Nexplanon placement procedure but prior to conclusion of the procedural visit.
measure: Overall Nexplanon placement experience
timeFrame: Upon completion of Nexplanon placement procedure but prior to conclusion of procedural visit.
measure: Need for additional pain medication
timeFrame: Upon completion of Nexplanon placement procedure but prior to conclusion of procedural visit.
measure: Participants belief
timeFrame: Upon completion of Nexplanon placement but prior to conclusion of the procedural visit.
Other outcomes:
Locations:
Study officials:
affiliation: Obstetrics, Gynecology and Reproduc.ve Sciences, UCSD
name: Sheila Mody, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bentsianov SD, Brandi K, Chen P, Shimoni N. A Pilot Study to Understand the Adolescent Pain Experience During Contraceptive Implant Insertion. J Pediatr Adolesc Gynecol. 2021 Aug;34(4):522-524. doi: 10.1016/j.jpag.2021.01.013. Epub 2021 Jan 27.
citation: Nelson AL. Neutralizing pH of lidocaine reduces pain during Norplant system insertion procedure. Contraception. 1995 May;51(5):299-301. doi: 10.1016/0010-7824(95)00078-o.
citation: Mody SK, Farala JP, Jimenez B, Nishikawa M, Ngo LL. Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Sep;132(3):575-582. doi: 10.1097/AOG.0000000000002790.
citation: Azizkhani R, Forghani M, Maghami-Mehr A, Masomi B. The effects of injections of warmed bicarbonate-buffered Lidocaine as a painkiller for patients with trauma. J Inj Violence Res. 2015 Jul;7(2):87-8. doi: 10.5249/jivr.v7i2.523. Epub 2013 Dec 12. No abstract available.