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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06188221
• Other study ID #: 2019-05-0094
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: December 2023
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Hand Osteoarthritis
• Pain
• Trigger Finger
• Trigger Finger Disorder

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas Health Austin (UTHA)	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Jefferson scale of patient perception of physician empathy	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
Primary	Pain intensity during injection	11-point ordinal scale, with 0 for no pain at all and 10 for worst pain ever	During Injection
Primary	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
Primary	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
Primary	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	Pain intensity 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
Secondary	Pain intensity 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