Trigger Point Injections in Anterior Cervical Surgery

Официальное название

Comparison of Trigger Point Injections Versus Traditional Therapies in the Management of Postsurgical Pain in Patients Who Had Anterior Cervical Surgery

Обзор

To achieve appropriate exposure for an anterior neck surgery (for example an Anterior Cervical Discectomy and Fusion or ACDF), patients are positioned supine with their neck extended. Due to being in this position, patients frequently complain of posterior neck stiffness and pain postoperatively in addition to the anterior incisional pain. This posterior cervical pain can be classified as myofascial pain. Cervical myofascial pain is thought to be the result of overuse or trauma to the supporting muscles of the neck and shoulders. Trigger point injections are one of the methods used to treat myofascial pain. The trigger point injection procedure is where a physician (typically an anesthesiologist) performs an exam of the patient neck and upper back and finds areas of point tenderness. The physician will then inject a small amount of numbing medication (such as bupivacaine) into the muscle or tissue in that area. Trigger point injections have been shown to be superior to botox injections or dry needling, and equivalent to physical therapy. However, these studies were performed on patients with chronic neck pain. There are no studies evaluating the effectiveness of trigger point injections on post anterior cervical surgery patients. At our institution, trigger point injections with local anesthetic are used as part of a multimodal pain control regimen for post-anterior cervical surgery patients. Our hypothesis is if the addition of trigger point injections to standard of care multi-modal post-operative pain control will decrease patients' myofascial pain, and thereby decrease the amount of narcotic pain medication used.

Вмешательства

• Препарат Trigger point injection with bupivacaine
  Trigger point injections will be performed within an hour of arrival in post anesthesia care unit, given that the patient has adequately woken up from general anesthesia. Injections will be performed by an anesthesiology provider using a standardized technique under strict aseptic conditions. The trigger point will be located between two fingers, and a 1-2cm sterile needle with a thickness of 25 or 26 gauge inserted at 30 degrees with respect to the skin. Negative aspiration will be confirmed be
• Препарат Trigger point injection with normal saline
  Trigger point injections will be performed within an hour of arrival in post anesthesia care unit, given that the patient has adequately woken up from general anesthesia. Injections will be performed by an anesthesiology provider using a standardized technique under strict aseptic conditions. The trigger point will be located between two fingers, and a 1-2cm sterile needle with a thickness of 25 or 26 gauge inserted at 30 degrees with respect to the skin. Negative aspiration will be confirmed be
• Препарат Lidocaine skin wheal
  Patients in the control group will receive a small skin wheal of lidocaine. This will keep the patient blinded to the study group they are in since all patients will receive an injection. However, this skin wheal is not considered a trigger point injection.

Первичные конечные точки

• Opioid consumption in the first 6 hour period after intervention (trigger point injection/sham) [Срок оценки: 6 hours after intervention]
• Opioid consumption in the first 12 hour period after intervention (trigger point injection/sham) [Срок оценки: 12 hours after intervention]
• Opioid consumption in the first 24 hour period after intervention (trigger point injection/sham) [Срок оценки: 24 hours after intervention]

Вторичные конечные точки (4)

• Pain score at 6 hours after intervention (trigger point injection/sham) [Срок оценки: 6 hours after intervention]
• Pain score at 12 hours after intervention (trigger point injection/sham) [Срок оценки: 12 hours after intervention]
• Pain score at 24 hours after intervention (trigger point injection/sham) [Срок оценки: 24 hours after intervention]
• Post-operative length of stay [Срок оценки: Through hospital discharge, an average of 2 days]

Критерии участия

Критерии включения

• Elective anterior cervical surgery

Критерии исключения

• Emergency surgery
• Local anesthetic allergy
• Long term opioid usage (not including tramadol and codeine)
• Intra-operative complication (e.g. unstable cervical spine)

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

Лечение

Центры проведения

США · 1 центр

• George Washington University Hospital — Washington D.C.

Идентификаторы

NCT: NCT04640896 · NCR191932

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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