Anesthesia Clinical Trial
Official title:
Surgical Treatment of Carpal Tunnel Syndrome: Local Anesthesia With Epinephrine x Intravenous Regional Anesthesia. Randomized Clinical Trial.
The anesthetic technique of choice for surgical treatment of CTS varies among surgeons. In
the last decade some studies have described the performance of this surgery using local
anesthesia with adrenaline without the necessity of sedation or the use of pneumatic garrote,
having good effectiveness and substantial reduction of costs. However there is need for
studies with an appropriate design and methodology to evaluate the actual effectiveness of
this kind of anesthesia for the surgical treatment of CTS.
Objective: To evaluate the effectiveness and cost of open surgery for CTS in a randomized
trial comparing two anesthesia methods: intravenous regional anesthesia (Bier) and local
anesthesia with adrenaline without limb garroting (Lalondi).
Methods: This study was developed in the Group of Hand Surgery and Upper Limb; Department of
Orthopedics and Traumatology, Federal University of São Paulo, UNIFESP / EPM with
co-participation of the Hand Surgery and Microsurgery Department of Hospital Alvorada. This
study will be a Randomized Clinical Trial. The previous calculation of the sample resulted in
78 patients. The following primary outcomes will be assessed: Pain through visual analogue
scale (VAS). Costs: Costs related to anesthetic and surgical procedures will be recorded. The
secondary outcomes will be: Use of Analgesics, Anxiety and Depression through the HADS
(Hospital Anxiety and Depression Scale) scale. Quality of life through the Boston Carpal
Tunnel Syndrome Questionnaire (BCTQ). Remission of paresthesia after surgical intervention,
complications and failures.
Surgical treatment of CTS is most often performed under hospital conditions, with the use of
anesthesia. The anesthetic technique of choice varies among surgeons. In the last decade some
studies have described the performance of this surgery using local anesthesia with adrenaline
without the necessity of sedation or the use of pneumatic garrote, having good effectiveness
and substantial reduction of costs for the procedure with this anesthetic method. However,
when we evaluated the level and strength of the evidence from these studies, we notice that
there is a need for studies with an appropriate design and methodology to evaluate the actual
effectiveness of this kind of anesthesia for the surgical treatment of CTS.
Objective: To evaluate the effectiveness of open surgery for CTS in a randomized trial
comparing two anesthesia methods: intravenous regional anesthesia (Bier) and local anesthesia
with adrenaline without limb garroting (Lalondi).
Methods: This study was developed in the Group of Hand Surgery and Upper Limb; Department of
Orthopedics and Traumatology, Federal University of São Paulo, UNIFESP / EPM with
co-participation of the Hand Surgery and Microsurgery Department of the Medical Residency
Service in Hand Surgery of Hospital Alvorada. This study will be a Randomized Clinical Trial.
The previous calculation of the sample resulted in the need for total inclusion of 35
patients in each group, total of 70 patients, considering a loss of 10% during follow-up we
will include 78 patients. The following primary outcomes will be assessed: Pain through
visual analogue scale (VAS), that, will be measured in the pre-operative, transoperatory,
immediate postoperative, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours after surgery. Costs:
Costs related to anesthetic and surgical procedures will be recorded. The secondary outcomes
will be: Use of Analgesics, Anxiety and Depression through the HADS (Hospital Anxiety and
Depression Scale) scale. Quality of life through the Boston Carpal Tunnel Syndrome
Questionnaire (BCTQ). Remission of paresthesia after surgical intervention, complications and
failures.
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