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

January 19, 2025 updated by: Tel-Aviv Sourasky Medical Center

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

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tel Aviv, Israel
        • Tel Aviv Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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:
  • Local anasthesia
Patients without pre-injection local anesthesia prior to Intra-articular corticosteroid injection
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:
  • Local anasthesia

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.
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 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.
Questionnaire was given before the injection for anticipated pain evaluation,Beck Anxiety Inventory (BAI) and additional influencing factors on pain perception prior to injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Ehud Rath, Professor, Tel Aviv Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2021

Primary Completion (Actual)

January 2, 2022

Study Completion (Actual)

January 2, 2022

Study Registration Dates

First Submitted

December 31, 2024

First Submitted That Met QC Criteria

December 31, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 19, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLV-0674-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to medical confidentiality

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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