Trigger Point Injections in Anterior Cervical Surgery

George Washington University (GW)

Status and phase: Enrolling; Phase 4

Conditions: Pain, Back; Pain, Neck; Myofacial Pain; Cervical Fusion

Treatments: Drug: Lidocaine skin wheal; Drug: Trigger point injection with bupivacaine; Drug: Trigger point injection with normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04640896

NCR191932

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Lidocaine skin wheal

Sham Comparator group

Description:

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.

Treatment:

Drug: Lidocaine skin wheal

Trigger point injection with normal saline

Active Comparator group

Description:

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

Treatment:

Drug: Trigger point injection with normal saline

Trigger point injection with bupivacaine

Experimental group

Description:

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

Treatment:

Drug: Trigger point injection with bupivacaine