Clinical trial NCT04640896: Trigger Point Injections in Anterior Cervical Surgery
Official title: Comparison of Trigger Point Injections Versus Traditional Therapies in the Management of Postsurgical Pain in Patients Who Had Anterior Cervical Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Myofacial Pain
Pain, Neck
Pain, Back
Cervical Fusion
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Elective anterior cervical surgery

Exclusion Criteria:

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

Primary outcomes:
measure: Opioid consumption in the first 6 hour period after intervention (trigger point injection/sham)
timeFrame: 6 hours after intervention
measure: Opioid consumption in the first 12 hour period after intervention (trigger point injection/sham)
timeFrame: 12 hours after intervention
measure: Opioid consumption in the first 24 hour period after intervention (trigger point injection/sham)
timeFrame: 24 hours after intervention
Secondary outcomes:
measure: Pain score at 6 hours after intervention (trigger point injection/sham)
timeFrame: 6 hours after intervention
measure: Pain score at 12 hours after intervention (trigger point injection/sham)
timeFrame: 12 hours after intervention
measure: Pain score at 24 hours after intervention (trigger point injection/sham)
timeFrame: 24 hours after intervention
measure: Post-operative length of stay
timeFrame: Through hospital discharge, an average of 2 days
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
Study officials:
References: