Clinical trial NCT06760559: Does Pre-injection Local Anesthesia Affect Experienced Pain During Intra-articular Hip Injections.
Official title: Pain Scores Following Intrarticular Injections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Injection
Prevention
Assessment
Keywords: pain
injection
intra-articular
expectation
compliance
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2025-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing first-time intra-articular hip injection as indicated by an orthopedic surgeon either for diagnostic (e.g. lidocaine test, arthrography) and/or therapeutic (steroid injection for osteoarthritis) purposes.

Brief summary: 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.

Detailed description: 1. 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.
2. Data processing will be conducted by physicians holding an MD certification.
3. The type of study is prospective.
4. Data collection will be performed using the medical records of Tel Aviv Medical Center Hospital only, covering the years 2021 and 2022.
5. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Numeric rating scales (NRS) scores
timeFrame: 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 outcomes:
measure: Beck Anxiety Inventory (BAI) and fear of injections
timeFrame: Questionnaire was given before the injection for anticipated pain evaluation,Beck Anxiety Inventory (BAI) and additional influencing factors on pain perception prior to injection.
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
Study officials:
affiliation: Tel Aviv Medical Center
name: Ehud Rath, Professor
role: STUDY_DIRECTOR
References: