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

December 31, 2023 updated by: David Ring, University of Texas at Austin
The purpose of this study was to determine whether adding Lidocaine to Corticosteroid injections reduce pain intensity in hand surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

  • United States
    • Texas
      • Austin, Texas, United States, 78701
        • University of Texas Health Austin (UTHA)

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

Yes

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Corticosteroid with Lidocaine

The group with the lidocaine will get a combined injection with a steroid and lidocaine. The dosages depend on the disease. The steroid dosage will be the same as for the group without lidocaine.

  • Trigger finger/De Quervain's tenosynovitis/Tendonitis: 20mg kenalog (0.5mL of kenalog 40mg/mL suspension) + 5mg lidocaine (0,5mL 10mg/mL lidocaine solution)
  • Carpal tunnel injections: 6mg betamethasone (1mL of betamethasone 6mg/mL suspension) + 20mg lidocaine (2mL 10mg/mL lidocaine solution)
  • CMC/Basal joint arthritis: 3mg betamethasone (0.5mL of betamethasone 6mg/mL suspension) + 5mg lidocaine (0,5mL 10mg/mL lidocaine solution)
Drug: Lidocaine
The group with the lidocaine will get a combined injection with a corticosteroid and lidocaine. The dosages depend on the disease.
Drug: Corticoids
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:
Active Comparator: Corticosteroid without Lidocaine

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

  • Trigger finger/De Quervain's tenosynovitis/Tendonitis: 20mg kenalog (0,5mL of kenalog 40mg/mL suspension)
  • Carpal tunnel injections: 6mg betamethasone (1mL of betamethasone 6mg/mL suspension)
  • CMC/Basal joint arthritis: 3mg betamethasone (0,5mL of betamethasone 6mg/mL suspension)
Drug: Corticoids
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:

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During Injection
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)
through study completion, an average of 6 weeks
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)
through study completion, an average of 6 weeks
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)
through study completion, an average of 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 hours after injection
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
5 minutes after injection

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
through study completion, an average of 6 weeks

Collaborators and Investigators

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

Sponsor

University of Texas at Austin

Investigators

  • Principal Investigator: David Ring, MD, PhD, UT Health Austin

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)

February 1, 2020

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

July 8, 2019

First Submitted That Met QC Criteria

December 31, 2023

First Posted (Estimated)

January 3, 2024

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 31, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-05-0094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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