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

NCT ID: NCT06188221

Last Updated: 2024-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2023-07-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Hand Osteoarthritis Trigger Finger Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized in two groups for the corticosteroid injection, one group with lidocaine and one group without lidocaine.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
To make this a double-blind study, the medical assistant will put a piece of tape around the syringe to cover up the volume.

Study Groups

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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)

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

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

Corticoids

Intervention Type 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:

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)

Group Type ACTIVE_COMPARATOR

Corticoids

Intervention Type 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:

Interventions

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Lidocaine

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

Intervention Type 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:

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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David Ring

David Ring, MD, PhD Associate Dean for Comprehensive Care, Professor of Surgery and Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Ring, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Health Austin

Locations

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University of Texas Health Austin (UTHA)

Austin, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2019-05-0094

Identifier Type: -

Identifier Source: org_study_id

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