Pain Related to Local Anesthetic Administration for Nexplanon Placement
Conditions
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.
Interventions
COMBINATION_PRODUCTwe will prepare 3cc of buffered lidocaine consisting of 2.7cc of 1% lidocaine and 0.3cc of 8.4% sodium bicarbonate
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.
OTHERUnbuffered lidocaine
For the control, 3cc of unbuffered lidocaine will be prepared and administered by the clinician.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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?). |
Contacts
Primary ContactMcKensie M Wall, MD, MPH
Backup ContactSheila Mody, MD, MPH
Outcome results
None listed