Opioid Sparing Effect of an ISP Nerve Block on Post-Op Pain Control in Posterior Cervical Spine Surgery

Официальное название

The Opioid Sparing Effect of an Inter-semispinalis Plane Block on Postoperative Pain Control in Posterior Cervical Spine Surgery

Обзор

Participants who have a surgical procedure called Posterior Cervical (neck) Spine Surgery will normally need pain medication to relieve post operative pain. This usually includes opioid medications. In this study, the consented participant may receive a nerve block procedure, in addition to the pain relieving medication. There is a fifty-fifty chance to receive the nerve block. The goal is to see if the nerve block group needs less opioid medication, has lower pain scores and is discharged from the hospital sooner.

Подробное описание

The purpose of this research study is to evaluate the opioid-sparing effect of the use of an Inter-semispinalis plane (ISP) block after posterior cervical spine surgery.

Posterior cervical fusion (PCF) is a painful procedure that often requires the use of high doses of opioids to minimize postoperative pain. Uncontrolled pain can result in a delay in recovery and discharge. Additionally, high doses of opioids carry the risk of opioid dependence, and other side effects, include nausea, vomiting, sedation, and, in rare cases, respiratory depression. For all of the above reasons, reducing the use of opioids is of utmost importance.

Nerve blocks are one alternative to opioid use. The ISP block is a procedure described in 2017; it is a relatively simple procedure that entails injecting local anesthetic between two muscles in the back of the neck, bilaterally, to block the nerves that run in this plane. It is done under ultrasound guidance and, although a limited number of studies have shown promise, more data on its safety and efficacy are needed. The addition of Dexamethasone to local anesthetics, in nerve blocks, resulted in significant prolongation of the analgesia.

Вмешательства

• Процедура Inter-semispinalis Plane Block
  A nerve block targeting the dorsal rami of the cervical spinal nerves can help alleviate postoperative incisional pain.
• Препарат Opioids
  Routine Pain Management

Первичные конечные точки

• Lower opioid use [Срок оценки: 48 hours post Post-Anaesthesia Care Unit (PACU) arrival time]

Вторичные конечные точки (4)

• Lower opioid use. [Срок оценки: MME use will be recorded from the patient's Anesthesia induction time until the patient's PACU arrival time. This will be the intra-operative period, which may last several hours, but not expected to exceed eight hours.]
• Lower opioid use [Срок оценки: 24 hours after PACU arrival time]
• Pain Scores [Срок оценки: 48 hours after PACU arrival time]
• Length of hospital stay [Срок оценки: The patient's EMR will record the date and time of admission, as well as, the date and time of discharge. This will be quantified by the REDCap software being used for this study, and is not expected to exceed four days.]

Критерии участия

Критерии включения

• Having Posterior Cervical Spine Surgery from C2 - C7, which may extend to the upper thoracic vertebrae, inclusive to T3.
• Capacity to provide informed consent

Критерии исключения

• Fusion and decompression due to trauma
• Emergent procedures
• Patient is on a medication-assisted treatment, e.g., buprenorphine, naltrexone or methadone.
• There is an infection near or in the area of neck where the block will be placed.
• The patient is having a complicated surgery or a revision surgery
• Female patient with a positive pregnancy test on the day of surgery (hospital standard-of-care).
• Patient has Diabetes
• Patients who have had a prior adverse reaction to bupivacaine or dexamethasone
• Patients with Glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia

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

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Stony Brook University Hospital — Stony Brook

Идентификаторы

NCT: NCT06570577 · IRB2024-00227

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗