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Surgical Dressings After Endoscopic Carpal Tunnel Release

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04070924
Enrollment
0
Registered
2019-08-28
Start date
2024-03-31
Completion date
2024-03-20
Last updated
2024-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

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.

Interventions

OTHERBandaid

Bandaid dressing

OTHERConventional bulky soft tissue dressing

Conventional bulky soft tissue dressing

Sponsors

Chris Grandizio
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scale Pain Score0-12 monthsbest 0-10 worst; continuous scale to measure current pain level

Secondary

MeasureTime frameDescription
PROMIS Pain Interference0-12 monthsbest 0-100 worst; measures the effects of a patient's pain on their daily activities and lifestyle
PROMIS Self-Efficacy Manage Symptoms0-12 monthsbest 0-100 worst; measures a patient's ability to cope with their symptoms related to the procedure
PROMIS Upper Extremity0-12 monthsworst 0-100 best; measures physical function of upper extremities
QuickDASH0-12 monthsbest 0-100 worst; functional outcome score for disabilities of the arm, shoulder, and hand
number of participants with unscheduled healthcare contact0-12 monthsunscheduled healthcare contact includes patient calls/messages, emergency room visits, or scheduled clinic visits
Boston Carpal Tunnel Questionnaire0-12 monthsranges 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 complications0-12 monthscomplications after surgery including infection and delayed healing
Satisfaction with overall outcome0-12 months11 point Likert scale; worst 0-10 best
Satisfaction postoperative pain control0-12 months11 point Likert scale; worst 0-10 best
Satisfaction with the dressing0-12 months11 point Likert scale; worst 0-10 best
Grip Strength Measurement0-12 monthsUsing Jamar Hand Dynamometer, in kilograms ranging from worst 0-90 best
morphine equivalents0-12 monthsmorphine equivalents consumed for post-operative pain control

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026