Pain Related to Local Anesthetic Administration for Nexplanon Placement

Официальное название

Pain Related to Local Anesthetic Administration for Nexplanon Placement: A Randomized Control Trial of Buffered Lidocaine

Обзор

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.

Вмешательства

• Комбинированный продукт we 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 bicarbonat
• Другое Unbuffered lidocaine
  For the control, 3cc of unbuffered lidocaine will be prepared and administered by the clinician.

Первичные конечные точки

• Magnitude of pain at time of local anesthesia for Nexplanon placement [Срок оценки: Will assess pain immediately upon completion of the respective step (i.e. at completion of administration of local anesthetic)]

Вторичные конечные точки (8)

• Anticipated pain, prior to anesthetic administration [Срок оценки: Will assess anticipated pain immediately prior to anesthetic administration]
• Baseline pain [Срок оценки: At one point in time occurring at some point from the time of enrollment but prior to Nexplanon placement procedure]
• Pain with Nexplanon placement [Срок оценки: Will assess pain associated with Nexplanon placement immediately upon completion of this step]
• Pain associated with overall procedure [Срок оценки: Will assess pain associated with overall procedure immediately following conclusion of Nexplanon placement procedure]
• Patient satisfaction [Срок оценки: Following completion of Nexplanon placement procedure but prior to conclusion of the procedural visit.]
• Overall Nexplanon placement experience [Срок оценки: Upon completion of Nexplanon placement procedure but prior to conclusion of procedural visit.]
• Need for additional pain medication [Срок оценки: Upon completion of Nexplanon placement procedure but prior to conclusion of procedural visit.]
• Participants belief [Срок оценки: Upon completion of Nexplanon placement but prior to conclusion of the procedural visit.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07008222 · 812038

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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