Trigger Point Injections in Anterior Cervical Surgery

Sponsor

George Washington University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04640896

Collaborator

(none)

Enrollment

Location

Arms

25.8

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myofacial Pain Pain, Neck Pain, Back Cervical Fusion	Drug: Trigger point injection with bupivacaine Drug: Trigger point injection with normal saline Drug: Lidocaine skin wheal	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Comparison of Trigger Point Injections Versus Traditional Therapies in the Management of Postsurgical Pain in Patients Who Had Anterior Cervical Surgery

Actual Study Start Date :

Nov 5, 2020

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: 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.	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.
Active Comparator: 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	Drug: Trigger point injection with normal saline Trigger point injections will be performed within an hour of arrival in PACU, 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.
Experimental: Trigger point injection with bupivacaine Trigger point injections in the rhomboid and trapezius regions with up to 20cc of 0.25% bupivacaine HCl + intra- and postoperative standardized analgesia regimen	Drug: Trigger point injection with bupivacaine Trigger point injections will be performed within an hour of arrival in PACU, 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.

Arm

Intervention/Treatment

Sham Comparator: 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.

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.

Active Comparator: 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

Drug: Trigger point injection with normal saline

Trigger point injections will be performed within an hour of arrival in PACU, 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.

Experimental: Trigger point injection with bupivacaine

Trigger point injections in the rhomboid and trapezius regions with up to 20cc of 0.25% bupivacaine HCl + intra- and postoperative standardized analgesia regimen

Drug: Trigger point injection with bupivacaine

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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 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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	George Washington University Hospital	Washington	District of Columbia	United States	20037

Sponsors and Collaborators

George Washington University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anita Vincent, Assistant Professor of Anesthesiology and Critical Care, George Washington University

ClinicalTrials.gov Identifier:

NCT04640896

Other Study ID Numbers:

NCR191932

First Posted:

Nov 23, 2020

Last Update Posted:

Apr 19, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2021