Pain Related to Local Anesthetic Administration for Nexplanon Placement

NCT07008222 | Not Yet Recruiting

• 1 other identifier: 812038
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain Related to Local Anesthetic Administration for Nexplanon Placement

Outcome Measures

Primary Outcomes (1)

• Magnitude of pain at time of local anesthesia for Nexplanon placement

  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

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

Secondary Outcomes (8)

• Anticipated pain, prior to anesthetic administration

  Will assess anticipated pain immediately 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

• Pain with Nexplanon placement

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

• Pain associated with overall procedure

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

• Patient satisfaction

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

Study Arms (2)

Buffered Lidocaine Anesthetic Group

EXPERIMENTAL

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

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

3cc of unbuffered 1% lidocaine

Other: Unbuffered lidocaine

Interventions

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.

Buffered Lidocaine Anesthetic Group

Unbuffered lidocaine OTHER

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

Un-buffered Lidocaine Anesthetic Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Related Publications (4)

• 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.

  PMID: 33515699 BACKGROUND

• 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.

  PMID: 7628204 BACKGROUND

• 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.

  PMID: 30095776 BACKGROUND

• 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.

  PMID: 24879075 BACKGROUND

MeSH Terms

Interventions

Lidocaine; Sodium Bicarbonate

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Sheila Mody, MD, MPH

  Obstetrics, Gynecology and Reproduc.ve Sciences, UCSD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

McKensie M Wall, MD, MPH

CONTACT

858-249-1206; mmwall@health.ucsd.edu

Sheila Mody, MD, MPH

CONTACT

smody@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH, Obstetrics, Gynecology and Reproductive Sciences

Model Details: 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.

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 6, 2025
• Study Start: June 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-05