- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06760559
Does Pre-injection Local Anesthesia Affect Experienced Pain During Intra-articular Hip Injections.
Pain Scores Following Intrarticular Injections
Intra-articular hip injections are commonly used for diagnostic and therapeutic purposes but are often associated with patient anxiety and fear. The disparity between anticipated and experienced pain during these injections, as well as the role of pre-injection local anesthesia in pain modulation, remains unclear.
This study investigates the difference between anticipated and experienced pain during intra-articular hip injections. In addition, the study examines the impact of pre-injection local anesthesia in 60 prospectively recruited patients, some of whom received pre-injection local anesthesia while others did not. These study findings provide valuable insights into experienced pain during intra-articular hip injections, which can be applied to improve patient experiences and treatment compliance.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- Identification of patients in the outpatient clinic and completion of the questionnaires will be carried out by the principal investigator and sub-investigators in the clinic.
- Data processing will be conducted by physicians holding an MD certification.
- The type of study is prospective.
- Data collection will be performed using the medical records of Tel Aviv Medical Center Hospital only, covering the years 2021 and 2022.
- Demographic data will be collected, including gender, year of birth, age, diagnosis, indication for injection, and previous treatments. Clinical data will include underlying diseases, side of injection, complications, indications, and follow-up time.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Tel Aviv, Israel
- Tel Aviv Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing a first-time intra-articular hip injection as indicated by an orthopedic surgeon.
- Indications for injection include:
- Diagnostic purposes (e.g., lidocaine test, arthrography)
- Therapeutic purposes (e.g., steroid injection for osteoarthritis)
- Participants must be 18 years of age or older.
- No previous hip joint injections.
- Ability to fill in the survey questionnaire.
Exclusion Criteria:
- Patients under 18 years of age.
- Patients with a known history of hypersensitivity or allergy to the injectant material (e.g., local anesthetics, steroids).
- Patients lacking the ability to sign informed consent or complete a survey questionnaire.
- Patients with previous hip joint injections, due to the potential for recalling prior pain experienced.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Pre-injection superficial local anesthesia prior to Intra-articular corticosteroid injection
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Intra-articular hip injections with and without local anastesia and questionnaire about pain and anxiety related to the procedure was administered before and after the injection to the study and control groups.
Other Names:
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Patients without pre-injection local anesthesia prior to Intra-articular corticosteroid injection
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Intra-articular hip injections with and without local anastesia and questionnaire about pain and anxiety related to the procedure was administered before and after the injection to the study and control groups.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric rating scales (NRS) scores
Time Frame: Questionnaire was given before the injection for anticipated pain evaluation and additional influencing factors on pain perception prior to injection and right after the injection for actual experienced pain.
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Numeric rating scales (NRS) scores were measured before and after an injection in both, study and control groups to determine the anticipated pain compared to experienced pain after Intra-articular hip injection with or without local anasthesia.
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Questionnaire was given before the injection for anticipated pain evaluation and additional influencing factors on pain perception prior to injection and right after the injection for actual experienced pain.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Anxiety Inventory (BAI) and fear of injections
Time Frame: Questionnaire was given before the injection for anticipated pain evaluation,Beck Anxiety Inventory (BAI) and additional influencing factors on pain perception prior to injection.
|
Correlation of BAI scores and other injection-related factors including fear of pain, needle visualization, needle size, and prior injection experiences to pre-injection anticipated pain.
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Questionnaire was given before the injection for anticipated pain evaluation,Beck Anxiety Inventory (BAI) and additional influencing factors on pain perception prior to injection.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ehud Rath, Professor, Tel Aviv Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TLV-0674-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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