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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Un-buffered Lidocaine Anesthetic Group | Active Comparator | 3cc of unbuffered 1% lidocaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Will assess anticipated pain immediately prior to anesthetic administration |
| Baseline pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| McKensie M Wall, MD, MPH | Contact | 858-249-1206 | mmwall@health.ucsd.edu | |
| Sheila Mody, MD, MPH | Contact | smody@health.ucsd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sheila Mody, MD, MPH | Obstetrics, Gynecology and Reproduc.ve Sciences, UCSD | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33515699 | Background | 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. | |
| 7628204 | 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. |
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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.
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|
| Unbuffered lidocaine | Other | For the control, 3cc of unbuffered lidocaine will be prepared and administered by the clinician. |
|
Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) to describe pain at baseline |
| 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 | 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. | 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?). | 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). | 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. | 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). | Upon completion of Nexplanon placement but prior to conclusion of the procedural visit. |
| 30095776 | 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. |
| 24879075 | 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. |
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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