Trigger Point Injections in Anterior Cervical Surgery
Primary Purpose
Myofacial Pain, Pain, Neck, Pain, Back
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Trigger point injection with bupivacaine
Trigger point injection with normal saline
Lidocaine skin wheal
Sponsored by
About this trial
This is an interventional treatment trial for Myofacial Pain
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)
Sites / Locations
- George Washington University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Active Comparator
Experimental
Arm Label
Lidocaine skin wheal
Trigger point injection with normal saline
Trigger point injection with bupivacaine
Arm Description
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 injections in the rhomboid and trapezius regions with up to 20cc of 0.9% Normal Saline + intra- and postoperative standardized analgesia regimen
Trigger point injections in the rhomboid and trapezius regions with up to 20cc of 0.25% bupivacaine hydrochloride + intra- and postoperative standardized analgesia regimen
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Post-operative length of stay
Measured in days and hours
Full Information
NCT ID
NCT04640896
First Posted
November 13, 2020
Last Updated
December 7, 2022
Sponsor
George Washington University
1. Study Identification
Unique Protocol Identification Number
NCT04640896
Brief Title
Trigger Point Injections in Anterior Cervical Surgery
Official Title
Comparison of Trigger Point Injections Versus Traditional Therapies in the Management of Postsurgical Pain in Patients Who Had Anterior Cervical Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofacial Pain, Pain, Neck, Pain, Back, Cervical Fusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine skin wheal
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Trigger point injection with normal saline
Arm Type
Active Comparator
Arm Description
Trigger point injections in the rhomboid and trapezius regions with up to 20cc of 0.9% Normal Saline + intra- and postoperative standardized analgesia regimen
Arm Title
Trigger point injection with bupivacaine
Arm Type
Experimental
Arm Description
Trigger point injections in the rhomboid and trapezius regions with up to 20cc of 0.25% bupivacaine hydrochloride + intra- and postoperative standardized analgesia regimen
Intervention Type
Drug
Intervention Name(s)
Trigger point injection with bupivacaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Trigger point injection with normal saline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine skin wheal
Intervention Description
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 Measure Information:
Title
Opioid consumption in the first 6 hour period after intervention (trigger point injection/sham)
Description
Cumulative dose of opioid medications utilized in the time period. Measured in oral morphine equivalents.
Time Frame
6 hours after intervention
Title
Opioid consumption in the first 12 hour period after intervention (trigger point injection/sham)
Description
Cumulative dose of opioid medications utilized in the time period. Measured in oral morphine equivalents.
Time Frame
12 hours after intervention
Title
Opioid consumption in the first 24 hour period after intervention (trigger point injection/sham)
Description
Cumulative dose of opioid medications utilized in the time period. Measured in oral morphine equivalents.
Time Frame
24 hours after intervention
Secondary Outcome Measure Information:
Title
Pain score at 6 hours after intervention (trigger point injection/sham)
Description
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 intervention
Title
Pain score at 12 hours after intervention (trigger point injection/sham)
Description
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 intervention
Title
Pain score at 24 hours after intervention (trigger point injection/sham)
Description
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 intervention
Title
Post-operative length of stay
Description
Measured in days and hours
Time Frame
Through hospital discharge, an average of 2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
George Washington University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduard Shaykhinurov
Phone
202-823-4259
Email
eshaykhinurov@mfa.gwu.edu
First Name & Middle Initial & Last Name & Degree
Anita Vincent, MD
First Name & Middle Initial & Last Name & Degree
Eric Heinz, MD
First Name & Middle Initial & Last Name & Degree
Michael Rosner, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Trigger Point Injections in Anterior Cervical Surgery
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