Pain Related to Local Anesthetic Administration for Nexplanon PlacementNCT07008222
Pain Related to Local Anesthetic Administration for Nexplanon Placement
A study testing we will prepare 3cc of buffered lidocaine consisting of 2.7cc of 1% lidocaine and 0.3cc of 8.4% sodium bicarbonate and Unbuffered lidocaine in people with Pain Related to Local Anesthetic Administration for Nexplanon Placement, run by University of California, San Diego.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Related to Local Anesthetic Administration for Nexplanon Placement
- What is being tested?
- we will prepare 3cc of buffered lidocaine consisting of 2.7cc of 1% lidocaine and 0.3cc of 8.4% sodium bicarbonate and Unbuffered lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Sheila Mody, MD, MPH contact
About this study
Official title: Pain Related to Local Anesthetic Administration for Nexplanon Placement: A Randomized Control Trial of Buffered Lidocaine
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.
- Being tested
- we will prepare 3cc of buffered lidocaine consisting of 2.7cc of 1% lidocaine and 0.3cc of 8.4% sodium bicarbonate, Unbuffered lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
we will prepare 3cc of buffered lidocaine consisting of 2.7cc of 1% lidocaine and 0.3cc of 8.4% sodium bicarbonateCombination 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 lidocaineOther
For the control, 3cc of unbuffered lidocaine will be prepared and administered by the clinician.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Unbuffered lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: Will assess anticipated pain immediately prior to anesthetic administration
Baseline pain
Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) to describe pain at baseline
Measured: At one point in time occurring at some point from the time of enrollment but prior to Nexplanon placement procedure
Pain with Nexplanon placement
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
Measured: Will assess pain associated with Nexplanon placement immediately upon completion of this step
Pain associated with overall 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.
Measured: Will assess pain associated with overall procedure immediately following conclusion of Nexplanon placement procedure
Patient satisfaction
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?).
Measured: Following completion of Nexplanon placement procedure but prior to conclusion of the procedural visit.
Overall Nexplanon placement experience
We will assess patient satisfaction with the overall Nexplanon placement experience utilizing VAS scale (anchors 0 mm = not, 100 mm = extremely satisfied).
Measured: Upon completion of Nexplanon placement procedure but prior to conclusion of procedural visit.
Need for additional pain medication
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.
Measured: Upon completion of Nexplanon placement procedure but prior to conclusion of procedural visit.
Participants belief
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).
Measured: Upon completion of Nexplanon placement but prior to conclusion of the procedural visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain Related to Local Anesthetic Administration for Nexplanon PlacementStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheila Mody, University of California, San Diego
- Investigators
- Sheila Mody, MD, MPH, Principal investigator, Obstetrics, Gynecology and Reproduc.ve Sciences, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008222
- Sponsor's protocol ID
- 812038
- Status last verified
- May 2025
- First submitted
- 28 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33515699Nelson 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.
PubMed 7628204Mody 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.
PubMed 30095776Azizkhani 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.
PubMed 24879075
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Related to Local Anesthetic Administration for Nexplanon Placement: A Randomized Control Trial of Buffered Lidocaine
- ClinicalTrials.gov ID
- NCT07008222
- Acronym / sponsor ID
- 812038
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Buffered Lidocaine Anesthetic Group | Experimental | Combination Product: we will prepare 3cc of buffered lidocaine consisting of 2.7cc of 1% lidocaine and 0.3cc of 8.4% sodium bicarbonatewill 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 | Other: Unbuffered lidocaine3cc of unbuffered 1% lidocaine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| we will prepare 3cc of buffered lidocaine consisting of 2.7cc of 1% lidocaine and 0.3cc of 8.4% sodium bicarbonateEither 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. | Combination product | Buffered Lidocaine Anesthetic Group |
| Unbuffered lidocaineFor the control, 3cc of unbuffered lidocaine will be prepared and administered by the clinician. | Other | Un-buffered Lidocaine Anesthetic Group |
Primary outcome
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
8 secondary outcomes
Anticipated pain, prior to anesthetic administration
Time frame: Will assess anticipated pain immediately prior to anesthetic administration
Baseline pain
Time frame: At one point in time occurring at some point from the time of enrollment but prior to Nexplanon placement procedure
Pain with Nexplanon placement
Time frame: Will assess pain associated with Nexplanon placement immediately upon completion of this step
Pain associated with overall procedure
Time frame: Will assess pain associated with overall procedure immediately following conclusion of Nexplanon placement procedure
Patient satisfaction
Time frame: Following completion of Nexplanon placement procedure but prior to conclusion of the procedural visit.
Overall Nexplanon placement experience
Time frame: Upon completion of Nexplanon placement procedure but prior to conclusion of procedural visit.
Need for additional pain medication
Time frame: Upon completion of Nexplanon placement procedure but prior to conclusion of procedural visit.
Participants belief
Time frame: Upon completion of Nexplanon placement but prior to conclusion of the procedural visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Background: PubMed 33515699Bentsianov 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.
- Background: PubMed 7628204Nelson 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.
- Background: PubMed 30095776Mody 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.
- Background: PubMed 24879075Azizkhani 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sheila Mody, MD, MPH contact
Sheila Mody, MD, MPH principal investigator
Obstetrics, Gynecology and Reproduc.ve Sciences, UCSD
Questions about this trial
What is this clinical trial studying?
A study testing we will prepare 3cc of buffered lidocaine consisting of 2.7cc of 1% lidocaine and 0.3cc of 8.4% sodium bicarbonate and Unbuffered lidocaine in people with Pain Related to Local Anesthetic Administration for Nexplanon Placement, run by University of California, San Diego.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact McKensie M Wall, MD, MPH (858-249-1206, mmwall@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07008222, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.