Does Adding Lidocaine to Corticosteroid Injections Reduce Pain Intensity in Hand Surgery
Phase: NA
Conditions: Hand Osteoarthritis, Trigger Finger, Carpal Tunnel Syndrome
Sponsor: University of Texas at Austin

 
 
Does Adding Lidocaine to Corticosteroid Injections Reduce Pain 
Intensity in Hand Surgery? 
 
Date: 7-18-2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Hypotheses 
Primary null hypothesis:  
There is a difference in pain intensity during injection (directly assessed after the 
injection) between patients receiving corticosteroid injections in combination with 
lidocaine vs without lidocaine, for any hand/wrist injection. 
 
Secondary hypotheses:  
- 
There is a difference in pain intensity 4 hours after injection between patients 
receiving corticosteroid injections in combination with lidocaine vs without 
lidocaine, for any hand/wrist injection. 
 
As per some previous studies we will perform our other analyses based on superiority, 
without margins of non-inferiority, as this is only relevant for the analysis of the primary 
outcome. 
- 
There are no factors (including adding lido to corticosteroid injection) 
independently associated with pain intensity, satisfaction with the visit, and 
perceived empathy. 
 
Background and significance 
In patients with carpal tunnel syndrome, injection of glucocorticoids into the 
region of the carpal tunnel is intended to reduce tissue inflammation and aid recovery. 
[3] For trigger finger and de Quervain tendinopathy, glucocorticosteroid injection can 
cure the problem. [4;8] The corticosteroid injection is usually mixed with lidocaine. [3;4] 
Lidocaine is a local anesthetic commonly used in clinics and it is characterized by a rapid 
onset of action. [1] 
In case of trigger finger, a systematic review including two randomized trials, 
found that glucocorticosteroid injection was more effective for symptom relief than 
lidocaine injection alone. [5;6]. Dernek et al. shows no difference in efficacy between 
treatment for carpal tunnel syndrome with lidocaine and treatment with corticosteroid. 
[2] There’s a lack of evidence about the use of lidocaine injection as an addition to 
steroids against pain during injections. 
 
The average pain caused by corticosteroid injection for trigger finger is 4.3 on a 
scale of 10 when given with lidocaine. [7] Among other things, pain is correlated with 
expected pain, heightened illness concern, pain catastrophizing and depression, but not 
with prior injection or technique. [7] 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 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. 
 
Proposed methods 

 
 
Study design: Randomized Controlled Trial 
Recruitment methods (if applicable): 
All patients offered a corticosteroid injection will be invited to enroll in the 
middle of their visit prior to injection. A research assistant will obtain informed consent. 
Patients will be randomized, using a random number generator in Microsoft Excel, in 
two groups for the corticosteroid injection, one group with lidocaine and one group 
without lidocaine. Then the surgeon will give the corticosteroid injection. The group 
without the lidocaine will get an injection with only steroids. To make this a double-
blind study, the medical assistant will put a piece of tape around the syringe to cover up 
the volume. 
Data will be recorded on tablets using HIPAA compliant REDCap. After the 
injection, patients will be asked to complete a survey on REDCap in the following order: 
demographics, prior steroid injection, pain intensity, patient satisfaction with the visit, 
JSPPPE, PCS-4, PHQ-2, and PSEQ-2. This will take the patients 5 minutes to complete. A 
research assistant will ask the surgeon for the diagnosis, initial treatment, approach of 
injection and intrasheath or extrasheath injection. The medical assistant will complete 
the use of lidocaine in addition to corticosteroid injection, any other added substances 
and the volume of the injection. 
After 4 hours, the research assistant will do the follow up call and ask for the 
pain intensity. 
 
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 
 
Measured variables 
Response variables: 
- 
Pain intensity in the last 7 days 
o 11-point ordinal scale, with 0 for no pain at all and 10 for worst pain ever 
- 
Pain intensity during injection 
o 11-point ordinal scale, with 0 for no pain at all and 10 for worst pain ever 
- 
Pain intensity 5 minutes after injection 
o 11-point ordinal scale, with 0 for no pain at all and 10 for worst pain ever 
- 
Pain intensity 4 hours after injection 
o 11-point ordinal scale, with 0 for no pain at all and 10 for worst pain ever 
- 
Patient satisfaction with the visit, direct after visit and after 4 hours 
o 11-point ordinal scale, with 0 for not satisfied at all and 10 for most 
satisfied)  
- 
Perceived empathy 

 
 
o JSPPPE 
 
Explanatory variables: 
- 
Use of lidocaine in addition to corticosteroid (Yes / No) 
- 
Total volume of injection 
- 
Approach of injection 
- 
Intrasheath or extrasheath injection 
- 
Diagnosis 
- 
Initial treatment 
- 
Prior steroid injection anywhere 
o Prior steroid injection at that site 
- 
Abbreviated Pain Catastrophizing Scale (PCS 4) 
- 
Patient Health Questionnaire (PHQ 2) 
- 
Pain Self-efficacy Questionnaire (PSEQ 2) 
- 
Patient demographics 
o Sex (female, male) 
o Age (text) 
o Race/ethnicity (1. White, 2. Black/African American, 3. Latino, 4. Other. 
o Marital status (1. Married/Unmarried Couple, 2. Divorced/Separated, 3. 
Widowed, 4. Single.) 
o Level of education (1. High school or less, 3. 2-year college, 4. 4-year 
college, 5. Post-college graduate degree) 
o Work status 1. Employed, 2. Out of Work, 3. Unable to Work, 4. Retired) 
o Insurance status (1. Medicare/Medicaid, 2. Commercial, 3. Uninsured, 4. 
Worker compensation, 5. Other) 
 
 
Statistical analysis 
Intention to treat analysis may bias a non-inferiority trial towards finding no difference. 
Therefore, we will perform both an intention to treat and per protocol analysis. 
 
Primary and secondary null hypothesis 
Unpaired t-test for hypothesis testing and MV linear regressions for other hypotheses. 
 
A priori power analysis 
The primary outcome will be the difference in pain immediately after the injection after 
randomization between corticosteroid shots without lidocaine compared with adding 
lidocaine. 
 
We aim to assess the non-inferiority of corticosteroid shots without lidocaine compared 
with adding lidocaine. The difference in pain score will be compared by unpaired t-test. 
We will also report the mean, with SD and 95% CI and the mean difference with 95% 
confidence interval. We anticipate a mean pain score of 8.0 (95% CI 7.6 to 8.4) with a 
standard deviation of 1 for the shots with lidocaine. Non-inferiority will be considered if 

 
 
the pain score after shots without lidocaine is no more than 0.5 points lower. We aim to 
achieve 90% power to confirm non-inferiority, with a one-sided confidence level of 95%. 
Power calculation shows we need to include 138 patients (69 per group). Accounting for 
5% loss, we aim to include 145 patients, with 72-73 patients per group. 
 
Stata command: ssi 8.0 7.5, sd1(1) alpha(0.05) non power(0.9) 
 
 
References: 
1.  Lidocaine Test Increases the Success Rates of Corticosteroid Injection in 
Impingement Syndrome. Kim et al. Pain Med. 2016 Oct;17(10):1814-1820. Epub 
2016 Mar 5. 
2. Comparison of the efficacy of lidocaine and betamethasone dipropionate in 
carpal tunnel syndrome injection. Dernek et al. J Back Musculoskelet 
Rehabil. 2017;30(3):435-440. doi: 10.3233/BMR-150477. 
3. Up to date; Carpal tunnel syndrome: Treatment and prognosis 
4. Up to date; Trigger finger (stenosing flexor tenosynovitis) 
5. Lambert MA, Morton RJ, Sloan JP. Controlled study of the use of local steroid 
injection in the treatment of trigger finger and thumb. J Hand Surg Br 1992; 
17:69. 
6. Peters-Veluthamaningal C et al. Corticosteroid injection for trigger finger in 
adults. Cochrane Database Syst Rev 2009; :CD005617. 
7. Abhishek. Et al. Predictors of pain during and the day after corticosteroid 
injection for idiopathic trigger finger. The journal of hand surgery Volume 37, 
Issue 2, February 2012, Pages 237-242 
8. Up to date; de Quervain tendinopathy