Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory Strategy

Prospective controlled clinical trial in which a minimally invasive microsurgical approach was used following the keyhole principle in 55 patients and 65 hands under local anesthesia and ambulatory strategy. All patients included in the study had an average of 3 months disease course and were considered refractory to conservative treatment. Patients were evaluated with stringent inclusion criteria with the Levine severity and functional status scale with a 2 year follow-up. Descriptive outcomes on the efficiency of this procedure are reported.

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Key information

Conditions

Carpal Tunnel Syndrome Charcot-Marie-Tooth Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cumulative Trauma Disorders Entrapment Neuropathy Genetic Diseases, Inborn Hereditary Sensory and Motor Neuropathy Heredodegenerative Disorders, Nervous System Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Signs and Symptoms Sprains and Strains Wounds and Injuries

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Prospective clinical study to analyze 55 patients with carpal tunnel syndrome treated with open minimally invasive approach in 65 hands, using local anesthesia without tourniquet and in an ambulatory setting.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with confirmed diagnosis who had neurologic exam, electromyography, cervical spine X rays showing no structural disturbances and with at least 3 months of persistent pain refractory to medical management and physical therapy.

Exclusion criteria

Patients with a history of direct trauma or orthopedic lesions in the carpal region, endocrine and/or metabolic disturbances (hypothyroidism, diabetes) and those that had previous local administration of steroids were excluded.

Treatment and study plan

keyhole approach

Procedure

The surgical procedure was a direct microsurgical approach with a 1.5 cm incision in the thenar sulcus, under local anesthesia (3cc, 2% lidocaine) administered with an insulin needle. The keyhole approach applied to this anatomical region is based on a 1.5 cm skin incision from where the 0.5 cm dissection is completed in the subcutaneous plane in the side borders and 1cm in the distal and proximal borders. Thus, the subcutaneous phase of the dissection is completed with separation of the carpal ligament and resection of its borders. Once the transverse fibers are open, the perineural micro adhesions of the median nerve are resected and 3mm of the free borders of the carpal fibers found on the nerve are removed to avoid fibrosis. The wound is checked for hemostasis and closed in apposition with Vicryl 3-0 and a single subdermal 3-0 Nylon stitch.

Primary outcomes

Levine Severity Scale

Time frame: 2 years follow up

pain grades with 5 grades of intensity

Sponsors and collaborators

Lead sponsor

Ivan Segura Duran

Other

Registry information

Official study title

Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2016
First posted: Feb 23, 2017
Registry last updated: Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed