Clinical trial NCT04070924: Surgical Dressings After Endoscopic Carpal Tunnel Release
Official title: Surgical Dressings After Endoscopic Carpal Tunnel Release: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale Pain Score
timeFrame: 0-12 months
Secondary outcomes:
measure: Boston Carpal Tunnel Questionnaire
timeFrame: 0-12 months
measure: PROMIS Pain Interference
timeFrame: 0-12 months
measure: PROMIS Self-Efficacy Manage Symptoms
timeFrame: 0-12 months
measure: PROMIS Upper Extremity
timeFrame: 0-12 months
measure: QuickDASH
timeFrame: 0-12 months
measure: number of participants with unscheduled healthcare contact
timeFrame: 0-12 months
measure: morphine equivalents
timeFrame: 0-12 months
measure: number of participants with complications
timeFrame: 0-12 months
measure: Satisfaction with overall outcome
timeFrame: 0-12 months
measure: Satisfaction postoperative pain control
timeFrame: 0-12 months
measure: Satisfaction with the dressing
timeFrame: 0-12 months
measure: Grip Strength Measurement
timeFrame: 0-12 months
Other outcomes:
Locations:
Study officials:
affiliation: Geisinger Clinic
name: Christopher Grandizio, MD
role: PRINCIPAL_INVESTIGATOR
References: