Surgical Dressings After Endoscopic Carpal Tunnel Release

Study Overview
=================
Brief Summary
-----------------
Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the upper extremity. While carpal tunnel release (CTR), both open (OCTR) and endoscopic (ECTR), is safe and effective, there are questions regarding the use of postoperative dressings after surgery. It is not currently known if dressing choices influence post-operative pain, function or patient satisfaction after ECTR. A less cumbersome dressing (bandaid) may allow patients to perform daily tasks with more ease after surgery. The purpose of this investigation is to compare postoperative pain scores and patient satisfaction after ECTR for patients treated with conventional post-operative bulky soft tissue dressings versus those treated with a bandaid after surgery. The hypothesis is that patients using a bandaid after surgery will have an easier time with functional tasks after surgery and that pain scores will not significantly differ between the two groups. Furthermore, this study aims to determine if there are differences in patient satisfaction, functional outcomes, complications, and unscheduled healthcare contact between these two groups. This will be a randomized, controlled investigation.

Detailed Description
-----------------
Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the upper extremity. While carpal tunnel release (CTR), both open (OCTR) and endoscopic (ECTR), is safe and effective, there are questions regarding the use of postoperative dressings after surgery. With recent attention to the opioid epidemic, there have been increasing efforts to reduce narcotic usage postoperatively while still controlling expected postoperative pain. Recent authors have found that many patients, particularly older patients, do not require any opioid analgesia after CTR with 47% of men and 36% of women consuming no narcotics after CTR (CHAPMAN). Furthermore, while splints have historically been used after surgery, their need has recently been questioned (LOGLI). It is not currently known if dressing choices influence post-operative pain, function or patient satisfaction after ECTR. A less cumbersome dressing (bandaid) may allow patients to perform daily tasks with more ease after surgery. The purpose of this investigation is to compare postoperative pain scores and patient satisfaction after ECTR for patients treated with conventional post-operative bulky soft tissue dressings versus those treated with a bandaid after surgery. The hypothesis is that patients using a bandaid after surgery will have an easier time with functional tasks after surgery and that pain scores will not significantly differ between the two groups. Furthermore, this study aims to determine if there are differences in patient satisfaction, functional outcomes, complications, and unscheduled healthcare contact between these two groups. This will be a randomized, controlled investigation.

Official Title
-----------------
Surgical Dressings After Endoscopic Carpal Tunnel Release: A Randomized Controlled Trial

Conditions
-----------------
Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Other: Bandaid
* Other: Conventional bulky soft tissue dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age or older Patients undergoing primary, elective, unilateral ECTR under monitored anesthesia care with local anesthesia. Exclusion Criteria: Patients undergoing ECTR as part of a worker's compensation case Patients currently incarcerated Subject who cannot read and speak English

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional post-operative bulky soft tissue dressing<br>Intraoperative: MAC-Local Anesthesia; Local anesthetic mixture will be distributed in both the subcutaneous tissue and within the carpal canal Postoperative: Non-opioid medications only; Conventional post-operative bulky soft tissue dressing (Xeroform, 4x4s, Webril, Ace Wrap; Worn until first postoperative visit) | Other: Conventional bulky soft tissue dressing<br>* Conventional bulky soft tissue dressing<br>|
| Experimental: Bandaid post-operative dressing<br>Intraoperative: MAC-Local Anesthesia; Local anesthetic mixture will be distributed in both the subcutaneous tissue and within the carpal canal Postoperative: Non-opioid medications only; Bandaid over incision (Patient given an edema glove to wear starting post-operative day 1; Dressing change be changed post-operative day 2 and as needed after that) | Other: Bandaid<br>* Bandaid dressing<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale Pain Score | best 0-10 worst; continuous scale to measure current pain level | 0-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boston Carpal Tunnel Questionnaire | ranges from 1 to 5, with a higher score indicating greater disability; -specific measure of self-reported symptom severity and functional status | 0-12 months | 
| PROMIS Pain Interference | best 0-100 worst; measures the effects of a patient's pain on their daily activities and lifestyle | 0-12 months | 
| PROMIS Self-Efficacy Manage Symptoms | best 0-100 worst; measures a patient's ability to cope with their symptoms related to the procedure | 0-12 months | 
| PROMIS Upper Extremity | worst 0-100 best; measures physical function of upper extremities | 0-12 months | 
| QuickDASH | best 0-100 worst; functional outcome score for disabilities of the arm, shoulder, and hand | 0-12 months | 
| number of participants with unscheduled healthcare contact | unscheduled healthcare contact includes patient calls/messages, emergency room visits, or scheduled clinic visits | 0-12 months | 
| morphine equivalents | morphine equivalents consumed for post-operative pain control | 0-12 months | 
| number of participants with complications | complications after surgery including infection and delayed healing | 0-12 months | 
| Satisfaction with overall outcome | 11 point Likert scale; worst 0-10 best | 0-12 months | 
| Satisfaction postoperative pain control | 11 point Likert scale; worst 0-10 best | 0-12 months | 
| Satisfaction with the dressing | 11 point Likert scale; worst 0-10 best | 0-12 months | 
| Grip Strength Measurement | Using Jamar Hand Dynamometer, in kilograms ranging from worst 0-90 best | 0-12 months |