Does Pre-injection Local Anesthesia Affect Experienced Pain During Intra-articular Hip Injections.

Completed

• Conditions: Pain; Injection; Prevention; Assessment

• Registration Number: NCT06760559
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

Study Timeline

• Study Start: 2021-01-03
• Primary Completion: 2022-01-02
• Study Completion: 2022-01-02
• Study First Submitted: 2024-12-31
• Study First Submitted QC: 2024-12-31
• Status Verified: 2025-01
• Study First Posted: 2025-01-07
• Last Update Submitted: 2025-01-19
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Numeric rating scales (NRS) scores	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.	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.

Secondary Outcome Measures

Name	Time	Method
Beck Anxiety Inventory (BAI) and fear of injections	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.

Trial Locations

Locations (1)

Tel Aviv Medical Center; 🇮🇱 Tel Aviv, Israel