Trigger Point Injections in Anterior Cervical Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trigger point injection with bupivacaine, Trigger point injection with normal saline, Lidocaine skin wheal.
- Who it may be relevant to
- Registry conditions: Myofacial Pain, Pain, Neck, Pain, Back, Cervical Fusion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Trigger Point Injections Versus Traditional Therapies in the Management of Postsurgical Pain in Patients Who Had Anterior Cervical Surgery
Overview
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.
Interventions
- 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 be - 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 be - 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.
Primary outcome measures
- Opioid consumption in the first 6 hour period after intervention (trigger point injection/sham) [Time frame: 6 hours after intervention]
- Opioid consumption in the first 12 hour period after intervention (trigger point injection/sham) [Time frame: 12 hours after intervention]
- Opioid consumption in the first 24 hour period after intervention (trigger point injection/sham) [Time frame: 24 hours after intervention]
Secondary outcome measures (4)
- Pain score at 6 hours after intervention (trigger point injection/sham) [Time frame: 6 hours after intervention]
- Pain score at 12 hours after intervention (trigger point injection/sham) [Time frame: 12 hours after intervention]
- Pain score at 24 hours after intervention (trigger point injection/sham) [Time frame: 24 hours after intervention]
- Post-operative length of stay [Time frame: Through hospital discharge, an average of 2 days]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- George Washington University Hospital — Washington D.C.
Identifiers
NCT: NCT04640896 · NCR191932