Trigger Point Injections in Anterior Cervical Surgery

NCT04640896 | Recruiting Phase 4 FDA Drug

• 1 other identifier: NCR191932
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Pain score at 6 hours after intervention (trigger point injection/sham)

  6 hours after intervention

• Pain score at 12 hours after intervention (trigger point injection/sham)

  12 hours after intervention

• Pain score at 24 hours after intervention (trigger point injection/sham)

  24 hours after intervention

• Post-operative length of stay

  Through hospital discharge, an average of 2 days

Study Arms (3)

Lidocaine skin wheal

SHAM COMPARATOR

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

Trigger point injection with normal saline

ACTIVE COMPARATOR

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 injection with bupivacaine

EXPERIMENTAL

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

Interventions

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 bupivacaine

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.

Trigger point injection with normal saline

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.

Lidocaine skin wheal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective anterior cervical surgery

You may not qualify if:

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

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

George Washington University Hospital

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

RECRUITING

MeSH Terms

Conditions

Facial Pain; Neck Pain; Back Pain; Klippel-Feil Syndrome

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology and Critical Care

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 23, 2020
• Study Start: November 5, 2020
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)