MedPath

Surgical Dressings After Endoscopic Carpal Tunnel Release

Not Applicable
Withdrawn
Conditions
Carpal Tunnel Syndrome
Interventions
Other: Bandaid
Other: Conventional bulky soft tissue dressing
Registration Number
NCT04070924
Lead Sponsor
Chris Grandizio
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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  1. Patients 18 years of age or older
  2. Patients undergoing primary, elective, unilateral ECTR under monitored anesthesia care with local anesthesia.
Exclusion Criteria
  1. Patients undergoing ECTR as part of a worker's compensation case
  2. Patients currently incarcerated
  3. Subject who cannot read and speak English

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Bandaid post-operative dressingBandaid1. Intraoperative: MAC-Local Anesthesia; Local anesthetic mixture will be distributed in both the subcutaneous tissue and within the carpal canal 2. 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)
Conventional post-operative bulky soft tissue dressingConventional bulky soft tissue dressing1. Intraoperative: MAC-Local Anesthesia; Local anesthetic mixture will be distributed in both the subcutaneous tissue and within the carpal canal 2. Postoperative: Non-opioid medications only; Conventional post-operative bulky soft tissue dressing (Xeroform, 4x4s, Webril, Ace Wrap; Worn until first postoperative visit)
Primary Outcome Measures
NameTimeMethod
Visual Analog Scale Pain Score0-12 months

best 0-10 worst; continuous scale to measure current pain level

Secondary Outcome Measures
NameTimeMethod
Satisfaction with the dressing0-12 months

11 point Likert scale; worst 0-10 best

PROMIS Upper Extremity0-12 months

worst 0-100 best; measures physical function of upper extremities

QuickDASH0-12 months

best 0-100 worst; functional outcome score for disabilities of the arm, shoulder, and hand

Satisfaction with overall outcome0-12 months

11 point Likert scale; worst 0-10 best

PROMIS Self-Efficacy Manage Symptoms0-12 months

best 0-100 worst; measures a patient's ability to cope with their symptoms related to the procedure

morphine equivalents0-12 months

morphine equivalents consumed for post-operative pain control

PROMIS Pain Interference0-12 months

best 0-100 worst; measures the effects of a patient's pain on their daily activities and lifestyle

number of participants with complications0-12 months

complications after surgery including infection and delayed healing

Boston Carpal Tunnel Questionnaire0-12 months

ranges from 1 to 5, with a higher score indicating greater disability; -specific measure of self-reported symptom severity and functional status

number of participants with unscheduled healthcare contact0-12 months

unscheduled healthcare contact includes patient calls/messages, emergency room visits, or scheduled clinic visits

Satisfaction postoperative pain control0-12 months

11 point Likert scale; worst 0-10 best

Grip Strength Measurement0-12 months

Using Jamar Hand Dynamometer, in kilograms ranging from worst 0-90 best

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