Pectoral Block in Breast Reduction for Pain Control

Официальное название

Intraoperative Pectoral Block in Breast Reductions: Reduction in Pain Scores & Elimination of Narcotic Use

Обзор

A reduction mammoplasty is a commonly performed procedure for patients with symptomatic macromastia. The procedure involves removing breast parenchyma for an overall reduction in breast size and to alleviate patient symptoms, such as back/neck pain, rashes in the inframammary fold, and bra strap indentation. It is well documented in the literature that this procedure has a statistically significant reduction in patient symptoms. Postoperatively, it has been within the norm to prescribe narcotics in order to alleviate post-procedural pain. Recently, however, the research realm has advocated a non-narcotic multimodal pain control (MMPC) approach to minimize narcotic usage. Narcotic use is associated with increased costs in the healthcare system due to reported heightened pain scores for extended duration, constipation, nausea, vomiting, opiate dependence among other factors associated with increased morbidity. The goal of this study is to determine if PECs II (pectoral block type II) block alone is non-inferior to the standard multimodal pain control with narcotics for postoperative pain reduction in breast reduction.

Подробное описание

Participants will be initially identified and introduced to the study during preoperative breast reduction consultation in the office. Participants will be contacted via phone for the consenting process, and consented electronically, after their consultation. After completion of the consenting and enrollment process, participants will be entered into a software program will automatically randomize participants into a control group (MMPC including narcotics) and an experimental group (PECs II block, MMPC no narcotics). In the experimental group, participants are informed that additional pain control is not withheld and that a paper prescription for a narcotic will be provided. Participants will be informed to use this paper prescription in the event their pain is not adequately controlled in the experimental group. Participants in the control group will have a paper prescription for a narcotic as well to maintain the study's blindness. Participants will be sent surveys at postoperative days 1, 3, and 7 assessing patient pain control as a primary outcome (PROMIS Pain Intensity Survey) and secondary outcomes: narcotic usage and satisfaction level. If participants do not answer initial survey query after 24 hours, a follow up email or phone call will be completed to obtain the information on the following day. Statistical analysis will be performed on the primary outcome assessing non-inferiority between the two groups at all time points once at least 80 patients have enrolled in the study.

Description of PECs II Block: The participant will be administered 20 cc's of local anesthetic (0.25% bupivacaine with epinephrine), with 20 mcg dexmedetomidine and 4 mg dexamethasone added per breast. A total of 40 cc's of 0.25% bupivacaine will be used. This will be performed as a Pectoral II block. "The Pectoral II block is a modified Pectoral I block and can be achieved using a single needle stick. Local anesthetic placement is between the pectoralis major and pectoralis minor as for a Pecs I block and then between pectoralis minor and serratus anterior. The second portion of the procedure will block the anterior cutaneous branches of intercostal nerves 3 to 6, the intercostobrachial nerves, and the long thoracic nerve" (Battista et al). The standard of care injection, whether a nerve block or subcutaneous infiltration typically utilizes only a local anesthetic such as bupivacaine.

Multimodal Pain Regimen: Patients are advised to take 1000 mg of acetaminophen every 6 hours and 600 mg of ibuprofen every 6 hours both scheduled and staggered 3 hours apart. If patient weight \<100 kg, oxycodone 5 mg tab PO q6h PRN for pain score 8-10 will be prescribed; disp-10, no refill. If patient weight \>100 kg, oxycodone 10 mg tab PO q6h PRN for pain score 8-10 will be prescribed; disp-10, no refill.

Вмешательства

• Процедура Pectoral II Nerve Block
  The Pectoral II block is a modified Pectoral I block and can be achieved using a single needle stick. Local anesthetic placement is between the pectoralis major and pectoralis minor as for a Pecs I block and then between pectoralis minor and serratus anterior. The second portion of the procedure will block the anterior cutaneous branches of intercostal nerves 3 to 6, the intercostobrachial nerves, and the long thoracic nerve.
• Препарат Post Operative Pain Relievers
  Participants will receive the same postoperative instructions in both groups. Participants will be instructed to alternate acetaminophen and ibuprofen every 6 hours. Participants will also receive a paper prescription for a narcotic pain medication if pain is not adequately controlled by the over-the-counter products

Первичные конечные точки

• Postoperative pain control regimen [Срок оценки: From enrollment to completion of the study is approximately 3 weeks]
• Postoperative PROMIS pain intensity survey [Срок оценки: Surveys collected on days 1, 3, and 7 post-surgery. From enrollment to completion of the study is approximately 3 weeks]

Критерии участия

Критерии включения

• Undergoing breast reduction surgery
• Women older than age 18 and under age 75
• Stable breast size for at least 1 year
• Member has persistent symptoms in at least two of the anatomical body areas below, directly attributed to macromastia and affecting daily activities for at least 1 year:

Headaches; Pain in neck; Pain in shoulders; Pain in upper back; Painful kyphosis documented by X-rays; Pain/discomfort/ulceration from bra straps cutting into shoulders; Skin breakdown (severe soft tissue infection, tissue necrosis, ulceration hemorrhage) from overlying breast tissue; Upper extremity parasthesia

• Patient has evidence of severe breast hypertrophy that is documented by frontal and side profile photographs
• Pain symptoms persist as documented by the physician despite at least a 3-month trial of therapeutic measures such as:

Analgesic/non-steroidal anti-inflammatory drugs (NSAIDs) interventions and/or muscle relaxants Dermatologic therapy of ulcers, necrosis and refractory infection Physical therapy/exercises/posturing maneuvers Supportive devices (e.g., proper bra support, wide bra straps) Chiropractic care or osteopathic manipulative treatment Medically supervised weight loss program Orthopedic or spine surgeon evaluation of spinal pain

• Breast Reduction is likely to cause a reduction in patient symptoms
• Women 50 years of age or older are required to have a mammogram that was negative for cancer performed within the two years prior to the date of the planned reduction mammoplasty
• Greater than 40 kg in weight

Критерии исключения

• History of chronic pain controlled with prescribed narcotics
• English as non-primary language
• No access to email or internet
• Positive pre-surgery pregnancy test
• Women not of ages 18-75
• Less than 40 kg in weight

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Carilion Clinic — Roanoke

Публикации

• Wang K, Zhang X, Zhang T, Yue H, Sun S, Zhao H, Zhou P. The Efficacy of Ultrasound-guided Type II Pectoral Nerve Blocks in Perioperative Pain Management for Immediate Reconstruction After Modified Radical Mastectomy: A Prospective, Randomized Study. Clin J Pain. 2018 Mar;34(3):231-236. doi: 10.1097/AJP.0000000000000529. PMID 28654558
• Sercan O, Karaveli A, Ozmen S, Uslu A. Comparison of the Effects of Pectoral Nerve Block and Local Infiltration Anesthesia on Postoperative Pain for Breast Reduction Surgery: A Prospective Observational Study. Eurasian J Med. 2021 Jun;53(2):102-107. doi: 10.5152/eurasianjmed.2021.20111. PMID 34177291
• Nguyen, Minh MD; Bhardwaj, Priya MD; Goulart, Micheline MD; Huayllani, Maria T. MD; Arredondo, Sean MD; Mitchell, Kerry-Ann S. MD, PhD; Lehrman, Craig R. MD. Effectiveness of Pectoral Nerve Block in Breast Reduction: A Single Institution Experience. Plastic and Reconstructive Surgery - Global Open 10(10S):p 58, October 2022. | DOI: 10.1097/01.GOX.0000898612.51965.a1
• Aarab Y, Ramin S, Odonnat T, Garnier O, Boissin A, Molinari N, Marin G, Perrigault PF, Cuvillon P, Chanques G. Pectoral Nerve Blocks for Breast Augmentation Surgery: A Randomized, Double-blind, Dual-centered Controlled Trial. Anesthesiology. 2021 Sep 1;135(3):442-453. doi: 10.1097/ALN.0000000000003855. PMID 34195767
• Yesiltas S, Turkoz A, Calim M, Yilmaz S, Esen A, Daskaya H, Karaaslan K. Comparison of serratus plane block alone and in combination with pectoral type 1 block for breast cancer surgery: a randomized controlled study. Hippokratia. 2021 Jan-Mar;25(1):8-14. PMID 35221650
• Taylor GA, Panichella JC, Neusner A, Lo A, Vazquez D, Zhao H, Trehan G, Livelsberger J, Gassman AA. Pain Control after Reduction Mammaplasty with Combination Bupivacaine and Dexamethasone Regional Block: A Randomized Controlled Trial. Plast Reconstr Surg. 2023 Aug 1;152(2):217e-226e. doi: 10.1097/PRS.0000000000010198. Epub 2023 Jul 27. PMID 36728270
• Choi JB, Shim YH, Lee YW, Lee JS, Choi JR, Chang CH. Incidence and risk factors of postoperative nausea and vomiting in patients with fentanyl-based intravenous patient-controlled analgesia and single antiemetic prophylaxis. Yonsei Med J. 2014 Sep;55(5):1430-5. doi: 10.3349/ymj.2014.55.5.1430. PMID 25048507
• Santosa KB, Lai YL, Brummett CM, Oliver JD, Hu HM, Englesbe MJ, Blair EM, Waljee JF. Higher Amounts of Opioids Filled After Surgery Increase Risk of Serious Falls and Fall-Related Injuries Among Older Adults. J Gen Intern Med. 2020 Oct;35(10):2917-2924. doi: 10.1007/s11606-020-06015-6. Epub 2020 Aug 3. PMID 32748343

Идентификаторы

NCT: NCT07527039 · IRB-23-2101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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