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NCT Number: NCT04640896

Trigger Point Injections in Anterior Cervical Surgery

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.

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Key information

Conditions

Myofacial Pain Back Pain Bone Diseases Bone Diseases, Developmental Cervical Fusion Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dysostoses Facial Pain Klippel-Feil Syndrome Musculoskeletal Abnormalities Musculoskeletal Diseases Neck Pain Neurologic Manifestations Pain Pain, Back Pain, Neck Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Trigger point injection with bupivacaine

Drug

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.

Trigger point injection with normal saline

Drug

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.

Lidocaine skin wheal

Drug

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.

Primary outcomes

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

    Time frame: 6 hours after intervention

    Milligrams morphine equivalents (MME)

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

    Time frame: 12 hours after intervention

    Milligrams morphine equivalents (MME)

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

    Time frame: 24 hours after intervention

    Milligrams morphine equivalents

Secondary outcomes

  1. Pain Score at 6 Hours After Intervention (Trigger Point Injection/Sham).

    Time frame: 6 hours after intervention

    Pain score will be assessed using visual analog scale. 0 indicates no pain and 10 indicates the worst possible pain.

  2. Pain Score at 12 Hours After Intervention (Trigger Point Injection/Sham)

    Time frame: 12 hours after intervention

    Pain score will be assessed using visual analog scale. 0 indicates no pain and 10 indicates the worst possible pain.

  3. Pain Score at 24 Hours After Intervention (Trigger Point Injection/Sham)

    Time frame: 24 hours after intervention

    Pain score will be assessed using visual analog scale. 0 indicates no pain and 10 indicates the worst possible pain.

  4. Post-operative Length of Stay

    Time frame: Through hospital discharge, an average of 2 days

    Measured in days and hours

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 23, 2020
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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