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Completed

NCT Number: NCT06188221

Does Adding Lidocaine to Corticosteroid Injections Reduce Pain Intensity in Hand Surgery

The purpose of this study was to determine whether adding Lidocaine to Corticosteroid injections reduce pain intensity in hand surgery.

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Key information

Conditions

Hand Osteoarthritis Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Muscular Diseases Musculoskeletal Diseases Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Tendinopathy Tendon Entrapment Trigger Finger Trigger Finger Disorder Wounds and Injuries

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Austin (UTHA)

Austin, Texas, 78701, United States

About this study

There is a lack of evidence about the use of lidocaine injection as an addition to steroids against pain during injections. Adding lidocaine adds to the volume of the injection, which might increase pain. It's possible that injecting cortisone without any lidocaine would be more comfortable than with lidocaine.

The aim of this randomized controlled trial is to assess the difference in pain intensity (during the injection and 4 hours later) between patients receiving a corticosteroid injection with or without lidocaine in patients with a hand condition. Secondarily, the aim of this study is to assess factors independently associated with pain intensity, satisfaction with the visit, and perceived empathy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients offered a steroid injection in a hand surgeon's office
  • Aged 18-89 years
  • English speaking patients
  • Able to provide informed consent

Exclusion criteria

  • Non-English/Spanish speakers

Treatment and study plan

Lidocaine

Drug

The group with the lidocaine will get a combined injection with a corticosteroid and lidocaine. The dosages depend on the disease.

Corticoids

Drug

The group without the lidocaine will get an injection with only corticosteroids. The corticosteroid dosage depends on the disease and will be the same as for the group with the lidocaine:

Primary outcomes

  1. Pain intensity during injection

    Time frame: During Injection

    11-point ordinal scale, with 0 for no pain at all and 10 for worst pain ever

  2. Pain Catastrophizing Scale (PCS 4)

    Time frame: through study completion, an average of 6 weeks

    A 4 item questionnaire with a range of 0(no pain catastrophizing thoughts) to 16(maximum pain catastrophizing thoughts)

  3. Patient Health Questionnaire (PHQ 2)

    Time frame: through study completion, an average of 6 weeks

    a 2 item questionnaire measuring depression symptoms with a range of 0(no depression symptoms

    0 to 6(maximum depression symptoms)

  4. Pain Self-efficacy Questionnaire (PSEQ 2)

    Time frame: through study completion, an average of 6 weeks

    A measure of effective coping strategies with a range of 0(no coping strategy) to 12(maximum coping strategies)

Secondary outcomes

  1. Pain intensity 4 hours after injection

    Time frame: 4 hours after injection

    11-point ordinal scale, with 0 for no pain at all and 10 for worst pain ever

  2. Pain intensity 5 minutes after injection

    Time frame: 5 minutes after injection

    11-point ordinal scale, with 0 for no pain at all and 10 for worst pain ever

Other outcomes

  1. Jefferson scale of patient perception of physician empathy

    Time frame: through study completion, an average of 6 weeks

    a 5 item questionnaire of patient's perceived empathy with a range of 5(minimum perceived empathy) to 35( maximum perceived empathy)

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 3, 2024
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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