Surgical Dressings After Endoscopic Carpal Tunnel Release

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04070924
• Other study ID #: 2019-0474
• Status: Withdrawn
• Phase: N/A
• Start date: March 2024
• Est. completion date: March 20, 2024

Study information

• Verified date: April 2024
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 20, 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

Other:
• Bandaid
Bandaid dressing
• Conventional bulky soft tissue dressing
Conventional bulky soft tissue dressing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chris Grandizio

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale Pain Score	best 0-10 worst; continuous scale to measure current pain level	0-12 months
Secondary	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
Secondary	PROMIS Pain Interference	best 0-100 worst; measures the effects of a patient's pain on their daily activities and lifestyle	0-12 months
Secondary	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
Secondary	PROMIS Upper Extremity	worst 0-100 best; measures physical function of upper extremities	0-12 months
Secondary	QuickDASH	best 0-100 worst; functional outcome score for disabilities of the arm, shoulder, and hand	0-12 months
Secondary	number of participants with unscheduled healthcare contact	unscheduled healthcare contact includes patient calls/messages, emergency room visits, or scheduled clinic visits	0-12 months
Secondary	morphine equivalents	morphine equivalents consumed for post-operative pain control	0-12 months
Secondary	number of participants with complications	complications after surgery including infection and delayed healing	0-12 months
Secondary	Satisfaction with overall outcome	11 point Likert scale; worst 0-10 best	0-12 months
Secondary	Satisfaction postoperative pain control	11 point Likert scale; worst 0-10 best	0-12 months
Secondary	Satisfaction with the dressing	11 point Likert scale; worst 0-10 best	0-12 months
Secondary	Grip Strength Measurement	Using Jamar Hand Dynamometer, in kilograms ranging from worst 0-90 best	0-12 months