Trigger Point Injections in Anterior Cervical Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeorge Washington University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Elective anterior cervical surgery
Disqualifiers
Emergency surgery
Local anesthetic allergy
Long term opioid usage (not including tramadol and codeine)
Intra-operative complication (e.g. unstable cervical spine)
Trial design
Design model
Parallel
Treatments tested in this trial
Trigger point injection with bupivacaine
DrugTrigger 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
DrugTrigger 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
DrugPatients 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Lidocaine skin whealSham comparator 1 intervention
Group B: Trigger point injection with normal salineActive comparator 1 intervention
Group C: Trigger point injection with bupivacaineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 hours after intervention2
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.
Time frame
12 hours after intervention3
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.
Time frame
24 hours after interventionSecondary outcomes
1
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.
Time frame
6 hours after intervention2
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.
Time frame
12 hours after intervention3
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.
Time frame
24 hours after intervention4
Post-operative length of stay
Measured in days and hours
Time frame
Through hospital discharge, an average of 2 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov