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

NCT06760559 | Completed DMC

• 1 other identifier: TLV-0674-21
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Injection; Prevention; Assessment

Keywords

pain; injection; intra-articular; expectation; compliance

Outcome Measures

Primary Outcomes (1)

• Numeric rating scales (NRS) scores

  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.

  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 (1)

• 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.

Study Arms (2)

Pre-injection superficial local anesthesia prior to Intra-articular corticosteroid injection

Procedure: Intra-articular corticosteroid injection

Patients without pre-injection local anesthesia prior to Intra-articular corticosteroid injection

Procedure: Intra-articular corticosteroid injection

Interventions

Intra-articular corticosteroid injection PROCEDURE

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.

Also known as: Local anasthesia

Patients without pre-injection local anesthesia prior to Intra-articular corticosteroid injection; Pre-injection superficial local anesthesia prior to Intra-articular corticosteroid injection

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Pain; Patient Compliance

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Ehud Rath, Professor

  Tel Aviv Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 7, 2025
• Study Start: January 3, 2021
• Primary Completion: January 2, 2022
• Study Completion: January 2, 2022
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)