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

Not Applicable

Completed

• Conditions: Trigger Finger; Carpal Tunnel Syndrome; Hand Osteoarthritis
• Interventions: Drug: Lidocaine; Drug: Corticoids

• Registration Number: NCT06188221
• Lead Sponsor: University of Texas at Austin

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-07-08
• Study Start: 2020-02-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-31
• Last Update Submitted: 2023-12-31
• Study First Posted: 2024-01-03
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corticosteroid with Lidocaine	Corticoids	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)
Corticosteroid without Lidocaine	Corticoids	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)
Corticosteroid with Lidocaine	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)

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ 2)	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)
Pain Self-efficacy Questionnaire (PSEQ 2)	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)
Pain intensity during injection	During Injection	11-point ordinal scale, with 0 for no pain at all and 10 for worst pain ever
Pain Catastrophizing Scale (PCS 4)	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)

Secondary Outcome Measures

Name	Time	Method
Pain intensity 4 hours after injection	4 hours after injection	11-point ordinal scale, with 0 for no pain at all and 10 for worst pain ever
Pain intensity 5 minutes after injection	5 minutes after injection	11-point ordinal scale, with 0 for no pain at all and 10 for worst pain ever

Trial Locations

Locations (1)

University of Texas Health Austin (UTHA); 🇺🇸 Austin, Texas, United States