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

NCT06188221 | Completed

• 1 other identifier: 2019-05-0094
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hand Osteoarthritis; Trigger Finger; Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (4)

• Pain intensity 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)

  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)

  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)

  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 Outcomes (2)

• Pain intensity 4 hours after injection

  4 hours after injection

• Pain intensity 5 minutes after injection

  5 minutes after injection

Other Outcomes (1)

• Jefferson scale of patient perception of physician empathy

  through study completion, an average of 6 weeks

Study Arms (2)

Corticosteroid with Lidocaine

EXPERIMENTAL

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; Drug: Corticoids

Corticosteroid without Lidocaine

ACTIVE COMPARATOR

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

Interventions

Lidocaine DRUG

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

Corticosteroid with Lidocaine

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:

Corticosteroid with Lidocaine; Corticosteroid without Lidocaine

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Non-English/Spanish speakers

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas Health Austin (UTHA)

Austin, Texas, 78701, United States

Location

MeSH Terms

Conditions

Trigger Finger Disorder; Carpal Tunnel Syndrome

Interventions

Lidocaine; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• David Ring, MD, PhD

  UT Health Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: To make this a double-blind study, the medical assistant will put a piece of tape around the syringe to cover up the volume.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David Ring, MD, PhD Associate Dean for Comprehensive Care, Professor of Surgery and Psychiatry

Model Details: Patients will be randomized in two groups for the corticosteroid injection, one group with lidocaine and one group without lidocaine.

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: January 3, 2024
• Study Start: February 1, 2020
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)