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临床试验/NCT04640896
NCT04640896已完成4 期

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

George Washington University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年11月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Opioid Consumption in the First 6 Hour Period After Intervention (Trigger Point Injection/Sham)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Elective anterior cervical surgery

排除标准

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

研究组 & 干预措施

Trigger point injection with normal saline

Active Comparator

Trigger point injections in the rhomboid and trapezius regions with up to 20cc of 0.9% Normal Saline + intra- and postoperative standardized analgesia regimen

干预措施: Trigger point injection with normal saline (Drug)

Lidocaine skin wheal

Sham Comparator

They will receive an injection of lidocaine in the skin over the area of the trigger points. While this causes a small area of numbness, it is not a trigger point injection.

干预措施: Lidocaine skin wheal (Drug)

Trigger point injection with bupivacaine

Experimental

Trigger point injections in the rhomboid and trapezius regions with up to 20cc of 0.25% bupivacaine hydrochloride + intra- and postoperative standardized analgesia regimen

干预措施: Trigger point injection with bupivacaine (Drug)

结局指标

主要结局

Opioid Consumption in the First 6 Hour Period After Intervention (Trigger Point Injection/Sham)

时间窗: 6 hours after intervention

Milligrams morphine equivalents (MME)

Opioid Consumption in the First 12 Hour Period After Intervention (Trigger Point Injection/Sham)

时间窗: 12 hours after intervention

Milligrams morphine equivalents (MME)

Opioid Consumption in the First 24 Hour Period After Intervention (Trigger Point Injection/Sham)

时间窗: 24 hours after intervention

Milligrams morphine equivalents

次要结局

  • Pain Score at 6 Hours After Intervention (Trigger Point Injection/Sham).(6 hours after intervention)
  • Pain Score at 12 Hours After Intervention (Trigger Point Injection/Sham)(12 hours after intervention)
  • Pain Score at 24 Hours After Intervention (Trigger Point Injection/Sham)(24 hours after intervention)
  • Post-operative Length of Stay(Through hospital discharge, an average of 2 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Akhil Patel

Principal Investigator

George Washington University

研究点 (1)

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