Trigger Point Injections in Anterior Cervical Surgery
- Conditions
- Myofacial PainPain, NeckPain, BackCervical Fusion
- Interventions
- Drug: Trigger point injection with normal saline
- Registration Number
- NCT04640896
- Lead Sponsor
- George Washington University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Elective anterior cervical surgery
- Emergency surgery
- Local anesthetic allergy
- Long term opioid usage (not including tramadol and codeine)
- Intra-operative complication (e.g. unstable cervical spine)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lidocaine skin wheal 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. Trigger point injection with bupivacaine 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 Trigger point injection with normal saline 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
- Primary Outcome Measures
Name Time Method Opioid consumption in the first 12 hour period after intervention (trigger point injection/sham) 12 hours after intervention Cumulative dose of opioid medications utilized in the time period. Measured in oral morphine equivalents.
Opioid consumption in the first 24 hour period after intervention (trigger point injection/sham) 24 hours after intervention Cumulative dose of opioid medications utilized in the time period. Measured in oral morphine equivalents.
Opioid consumption in the first 6 hour period after intervention (trigger point injection/sham) 6 hours after intervention Cumulative dose of opioid medications utilized in the time period. Measured in oral morphine equivalents.
- Secondary Outcome Measures
Name Time Method Pain score at 12 hours after intervention (trigger point injection/sham) 12 hours after intervention Pain score will be assessed using visual analog scale. 0 indicates no pain and 10 indicates the worst possible pain.
Pain score at 6 hours after intervention (trigger point injection/sham) 6 hours after intervention Pain score will be assessed using visual analog scale. 0 indicates no pain and 10 indicates the worst possible pain.
Pain score at 24 hours after intervention (trigger point injection/sham) 24 hours after intervention Pain score will be assessed using visual analog scale. 0 indicates no pain and 10 indicates the worst possible pain.
Post-operative length of stay Through hospital discharge, an average of 2 days Measured in days and hours
Trial Locations
- Locations (1)
George Washington University Hospital
🇺🇸Washington, District of Columbia, United States