Surgical Dressings After Endoscopic Carpal Tunnel Release

NCT04070924 | Withdrawn

• 1 other identifier: 2019-0474
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale Pain Score

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

  0-12 months

Secondary Outcomes (12)

• Boston Carpal Tunnel Questionnaire

  0-12 months

• PROMIS Pain Interference

  0-12 months

• PROMIS Self-Efficacy Manage Symptoms

  0-12 months

• PROMIS Upper Extremity

  0-12 months

• QuickDASH

  0-12 months

Study Arms (2)

Conventional post-operative bulky soft tissue dressing

ACTIVE COMPARATOR

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)

Other: Conventional bulky soft tissue dressing

Bandaid post-operative dressing

EXPERIMENTAL

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)

Other: Bandaid

Interventions

Bandaid OTHER

Bandaid dressing

Bandaid post-operative dressing

Conventional bulky soft tissue dressing OTHER

Conventional bulky soft tissue dressing

Conventional post-operative bulky soft tissue dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older
• Patients undergoing primary, elective, unilateral ECTR under monitored anesthesia care with local anesthesia.

You may not qualify if:

• Patients undergoing ECTR as part of a worker's compensation case
• Patients currently incarcerated
• Subject who cannot read and speak English

Sponsors & Collaborators

• Chris Grandizio: lead

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Christopher Grandizio, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: August 24, 2019
• First Posted: August 28, 2019
• Study Start: March 1, 2024
• Primary Completion: March 1, 2024
• Study Completion: March 20, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04