Trials Today

Trigger Point Injections in Anterior Cervical Surgery

Purpose

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.

Conditions

Myofacial Pain
Pain, Neck
Pain, Back
Cervical Fusion

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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)

Study Design

Phase: Phase 4
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Single (Participant)

Arm Groups

Arm	Description	Assigned Intervention
Sham Comparator Lidocaine skin wheal	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.	Drug: 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.
Active Comparator Trigger point injection with normal saline	Trigger point injections in the rhomboid and trapezius regions with up to 20cc of 0.9% Normal Saline + intra- and postoperative standardized analgesia regimen	Drug: 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 before injecting the study solution. The needle will be withdrawn to the subcutaneous tissue and redirected superiorly, inferiorly, laterally and medially, injecting study solution at each location. Pressure will be applied to the area to ensure hemostasis, and the area dressed with gauze and tape as needed.
Experimental Trigger point injection with bupivacaine	Trigger point injections in the rhomboid and trapezius regions with up to 20cc of 0.25% bupivacaine hydrochloride + intra- and postoperative standardized analgesia regimen	Drug: 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 before injecting the study solution. The needle will be withdrawn to the subcutaneous tissue and redirected superiorly, inferiorly, laterally and medially, injecting study solution at each location. Pressure will be applied to the area to ensure hemostasis, and the area dressed with gauze and tape as needed.

Recruiting Locations

George Washington University Hospital
Washington D.C. 4140963, District of Columbia 4138106 20037

Contact:
Eduard Shaykhinurov
202-823-4259
eshaykhinurov@mfa.gwu.edu

More Details

NCT ID: NCT04640896
Status: Recruiting
Sponsor: George Washington University

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.