Other upper limb neuropathies
Conditions
Interventions
This is a prospective randomised study, a single-blind study, conducted at a reference center for orthopedics and traumatology in a high-complexity hospital in the state of São Paulo, Brazil. The stud
D000759
Sponsors
Hospital de Caridade São Vicente de Paulo.
Hospital de Caridade São Vicente de Paulo.
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adults scheduled for elective carpal tunnel release surgery. Minimum age of 18 years. Both sexes. Patients classified as ASA I or II (low surgical risk, according to the American Society of Anesthesiologists). Participants who underwent surgical treatment for Carpal Tunnel Syndrome (CTS) between December 2022 and April 2023
Exclusion criteria
Exclusion criteria: Patients under 18 years of age. Patients with contraindications for the use of tranexamic acid (TA), including renal insufficiency, history of seizures, vascular insufficiency, individuals with cognitive deficits or anxiety disorders that could compromise the agreed surgical technique
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study aims to evaluate complications, with a focus on bleeding severity, including severe or life-threatening hemorrhage. This was verified through postoperative monitoring of all participants. No patient experienced this complication. The occurrence of postoperative infection requiring surgical intervention (debridement) was assessed through clinical examination and laboratory tests, and was observed in one participant from Group 1 (Vasoconstrictor). The absence of ischemic events and conversion to the traditional technique (tourniquet use) was determined through intraoperative assessment, confirming no recorded cases. | — |
Secondary
| Measure | Time frame |
|---|---|
| The study seeks to analyze differences in surgical time between groups. This was assessed by recording the duration of procedures for each patient. The mean surgical time observed was 29.3 minutes for the TA group and 21.4 minutes for the Vasoconstrictor group. Additionally, intraoperative analysis aimed to determine the degree of difficulty in achieving hemostatic control. Evaluated through observational records, the TA group presented greater difficulty, requiring more frequent pauses for haemostasis, which led to a reduction in surgical field visibility.;The study aims to evaluate postoperative diagnostic tests and outcomes for Carpal Tunnel Syndrome (CTS). This was verified by comparing diagnostic test results between Groups 1 and 2. The tests showed similar results across both groups. The Phalen test demonstrated borderline significance in favor of the Vasoconstrictor group, where all patients had negative results (P = 0.07); however, the number of positive tests in the TA group was also low. The percentage of patients showing positive improvement between baseline and the 30-day follow-up diagnostic tests for CTS was comparable between the groups. The study also aims to analyze postoperative symptom comparison and functional scores (BCTQ). This was assessed through a 30-day follow-up of all patients. No significant differences were observed in postoperative symptom severity or functional status scores between the groups (P > 0.05). The comparison of Boston Questionnaire scores demonstrated similar results for symptom severity (P = 0.97) and functionality (P = 0.97). The difference between pre- and postoperative symptom scores was also similar for both groups (P = 0.47), with borderline significance in the difference between pre- and postoperative functional scores (P = 0.09). Despite these findings, the follow-up questionnaire scores were lower than baseline scores in both CTS diagnostic tests and the Boston Questionnaire, indicating improvements in pain and ha | — |
Countries
Brazil
Contacts
Public ContactJuliano Ajamil
Faculdade de Medicina de Jundiaí
Outcome results
None listed