Trigger Point Injections in Anterior Cervical Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Cervical Fusion; Pain, Back; Pain, Neck; Myofacial Pain
• Intervention / Treatment: Drug: Lidocaine skin wheal; Drug: Trigger point injection with normal saline; Drug: Trigger point injection with bupivacaine

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Recruiting
      • George Washington University Hospital
      • Contact: Eduard Shaykhinurov; Phone Number: 202-823-4259; Email: eshaykhinurov@mfa.gwu.edu
      • Principal Investigator: Anita Vincent, MD
      • Sub-Investigator: Eric Heinz, MD
      • Sub-Investigator: Michael Rosner, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption in the first 6 hour period after intervention (trigger point injection/sham)	Cumulative dose of opioid medications utilized in the time period. Measured in oral morphine equivalents.	6 hours after intervention
Opioid consumption in the first 12 hour period after intervention (trigger point injection/sham)	Cumulative dose of opioid medications utilized in the time period. Measured in oral morphine equivalents.	12 hours after intervention
Opioid consumption in the first 24 hour period after intervention (trigger point injection/sham)	Cumulative dose of opioid medications utilized in the time period. Measured in oral morphine equivalents.	24 hours after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score at 6 hours after intervention (trigger point injection/sham)	Pain score will be assessed using visual analog scale. 0 indicates no pain and 10 indicates the worst possible pain.	6 hours after intervention
Pain score at 12 hours after intervention (trigger point injection/sham)	Pain score will be assessed using visual analog scale. 0 indicates no pain and 10 indicates the worst possible pain.	12 hours after intervention
Pain score at 24 hours after intervention (trigger point injection/sham)	Pain score will be assessed using visual analog scale. 0 indicates no pain and 10 indicates the worst possible pain.	24 hours after intervention
Post-operative length of stay	Measured in days and hours	Through hospital discharge, an average of 2 days

Collaborators and Investigators

• Sponsor: George Washington University

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Anticipated): October 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 23, 2020

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Neck Pain; Facial Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Bupivacaine
• Other Study ID Numbers: NCR191932

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes