Surgical Dressings After Endoscopic Carpal Tunnel Release

NCT ID: NCT04070924

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2024-03-20

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional post-operative bulky soft tissue dressing

1. 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)

Group Type: ACTIVE_COMPARATOR

Conventional bulky soft tissue dressing

Intervention Type: OTHER

Conventional bulky soft tissue dressing

Bandaid post-operative dressing

1. 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)

Group Type: EXPERIMENTAL

Bandaid

Intervention Type: OTHER

Bandaid dressing

Interventions

Bandaid

Bandaid dressing

Intervention Type: OTHER

Conventional bulky soft tissue dressing

Conventional bulky soft tissue dressing

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chris Grandizio

OTHER

Sponsor Role: lead

Responsible Party

Chris Grandizio

Attending Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christopher Grandizio, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Other Identifiers

2019-0474

Identifier Type: -

Identifier Source: org_study_id