Stanford Univiersity
Redwood City, California, 94063, United States
NCT Number: NCT00756301
Interventional spine procedures are an increasingly popular means of diagnosis and treatment of spine disease. By convention, local anesthetics are used at the beginning of these procedures with the goal of minimizing pain. However, the infiltration of the local anesthetic is painful. This initial painful stimulus can heighten pain awareness and cause anxiety or excessive movement during the procedure.
The purpose of this study is to determine patient discomfort with administration of cutaneous local anesthetic prior to interventional spine procedures compared to no anesthetic administration for different gauge procedural needles. Another purpose is to determine patient discomfort with administration of local anesthetic by traditional technique compared to an alternative technique and to develop a standardized technique and criteria for local anesthetic administration during spine injection procedures that minimizes patient pain, and may help reduce the overall risk of these procedures.
We plan to enroll a total of 200-300 subjects coming to Stanford for symmetric bilateral single injections.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Redwood City, California, 94063, United States
Any patient referred by their treating physician for symmetric bilateral single injections (for example, bilateral transforaminal epidural injections, bilateral facet injections, or bilateral SI joint injections, etc.) will provide written informed consent before the procedure is conducted.
The contents of the consent forms will be used to explain the study to patients. Patients with pregnancy, coagulopathy, systemic infection, allergy to contrast dye, mentally disabled or those whom are unable to give informed consent will be excluded from the study.
Three different cutaneous local anesthetic techniques will be investigated, hereafter referred to as (a), (b), and (c), and described in detail here:
All data is collected during the procedure. There will be no follow-up visits after the procedure.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
1. Any patients referred by their treating physician for symmetric bilateral single injections (for example, bilateral transforaminal epidural injections, bilateral facet injections, or bilateral SI joint injections, etc.).
2.Ability to give informed consent. Exclusion Criteria:1.Pregnancy 2.Coagulopathy 3.Systemic infection 4.Allergy to contrast dye 5.Mentally disabled or those whom are unable to give informed consent 6.Those whom are unable to give informed consent in English 7.Prisoner
Local anesthetic (Lidocaine) injected using traditional technique (involves injecting Lidocaine into the skin first, then into the deeper tissues).
Time frame: At the time of the injection
Stanford University
Other
Cutaneous Administration of Local Anesthetic for Spine Injection Procedures: A Prospective Randomized Controlled Trial of Patient Preferred Method
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02886260
Back Injuries, Bone Diseases
Nîmes, France
View Trial DetailsNCT06828068
Bone Diseases, Musculoskeletal Disease
Hong Kong
View Trial DetailsNCT03832036
Back Pain, Bone Diseases
Frederiksberg, Denmark
View Trial DetailsNCT03533010
Bone Diseases, Bone Health
Hong Kong
View Trial Details