Anesthesia Tumescent for Surgical Management of Tenosynovitis.

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effectiveness of the tumescent anesthesia technique in the surgical management of hand tenosynovitis. For this, an open clinical trial was conducted, which included patients with hand tenosynovitis (carpal tunnel syndrome, trigger finger and Quervain syndrome), which were randomly assigned to a group. The control group was released pulleys and ligaments with local anesthetic technique and hemostasis with pneumatic tourniquet; While the study group was released from the pulleys and ligaments with tumescent anesthesia. The study variables were: anesthesia time, trans-surgical bleeding, pain, total procedure time and tissue reperfusion time.

Detailed Description
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Introduction: The WALANT technique (Wide Awake Local Anesthesia No-Torniquet) proposes the use of local anesthesia, epinephrine and tourniquet in the areas of the hand to be repaired, making costs and time and comfort more efficient. Objective: Evaluation of the effectiveness of the WALANT technique versus regional anesthesia with tourniquet in pain control, surgical management of stenosing tenosynovitis. Material and methods: Open clinical trial including patients with the trigger finger, tunnel syndrome in the operating room, candidates for surgery, and excluding previous surgeries at the site of the injury, hemodynamic instability, peripheral vascular diseases, smoking, anxiety, or psychiatric diseases. The anesthetic method was applied to the incision sites according to the diagnosis and the proposed procedure. At the end of the test, tumescent solution and control, 1% lidocaine plus pneumatic tourniquet on the forearm at 250mmHg. The main variables were: type of anesthesia and pain during the procedure. Descriptive and inferential statistics were applied (xi2, t-student or Mann-Whitney U).

Official Title
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Efficacy of Tumescent Local Anesthesia in the Surgical Management of Tenosynovitis.

Conditions
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Tenosynovitis

Intervention / Treatment
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* Combination Product: Tumescent Anesthesia
* Drug: Lidocaine
* Device: Pneumatic tourniquet
* Procedure: Open release of the tendon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Right holders of the Mexican Social Security Institute Over 18 years Trigger Finger Diagnosis Diagnosis of Carpal Tunnel Syndrome Diagnosis of Quervain Syndrome Acceptance and signature of informed consent Exclusion Criteria: Necessity for concomitant surgery Previous surgeries on the injured site Hemodynamic instability History of peripheral vascular diseases Do not wish to participate in the study Hypersensitivity to medication Smoking

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tumescent anesthesia<br>A tumescent solution was prepared; consisting of 40 cc of 0.9% Saline Solution, 10 cc of 2% Lidocaine, 0.4 cc of Epinephrine (1: 1000) and 4 cc of 7.5% Sodium Bicarbonate. This solution was applied in the incision sites according to the diagnosis and the proposed procedure. In case of trigger finger, 3 cc was applied subcutaneously in the proximal palmar crease of the affected finger; for Quervain syndrome, 5 to 6 cc of tumescent solution was injected along the first extensor compartment at the radial styloid level; and in the case of Carpal Tunnel Syndrome, 10 cc of tumescent solution was infiltrated on the flexor retinaculum in the subcutaneous tissue and from 7 to 10 cc below it. Subsequently, 20 minutes were waited for the epinephrine to cause vasoconstriction, and the asepsis of the limb was continued , sterile fields were placed, the incision site was corroborated and the surgical procedure proposed for each pathology was started. | Combination Product: Tumescent Anesthesia<br>* A tumescent solution is prepared with 2% lidocaine (10ml), 1:1000 epinephrine (0.4ml) and 7.5% sodium bicarbonate (4ml) dissolved in 0.9% saline solution (40ml) and applied from 3 to 20ml (depending on the pathology to be repaired) at the incision site.<br>Procedure: Open release of the tendon<br>* Standard surgical procedure for carpal tunnel syndrome, trigger finger and Quervain syndrome.<br>|
| Active Comparator: Local anesthesia with tourniquet.<br>Lidocaine 1% was applied to the incision sites according to the diagnosis and the proposed procedure. In case of trigger finger, 3 cc was applied subcutaneously in the proximal palmar crease of the affected finger; for Quervain syndrome, 5 to 6 cc were injected along the first extensor compartment at the radial styloid level; and in the case of Carpal Tunnel Syndrome, 10 cc was infiltrated on the flexor retinaculum in the subcutaneous tissue and from 7 to 10 cc below it. Afterwards, a pneumatic tourniquet was placed at the level of the forearm at 250 mmHg after exsanguination with a bandage from Esmarch. The asepsis of the limb was continued, sterile fields were placed, the incision site was corroborated and the surgical procedure proposed for each pathology was started. At the end of the surgical procedure, it was closed by planes, a soft bandage was placed, the tourniquet was removed and the patient was taken to recovery. | Drug: Lidocaine<br>* Apply 3 to 20 ml at the incision site, depending on the pathology to be repaired(carpal tunnel syndrome, trigger finger or Quervain syndrome).<br>* Other names: Lidocaine 1%;Device: Pneumatic tourniquet<br>* Level of the forearm at 250 mmHg, after exsanguination with Esmarch bandage.<br>Procedure: Open release of the tendon<br>* Standard surgical procedure for carpal tunnel syndrome, trigger finger and Quervain syndrome.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure pain: Visual Analog Scale | Evaluated by Visual Analog Scale, A subjective psychometric response scale used to measure distinct behavioral or physiological phenomena based on linear numerical gradient, with values from 0 to 10. In the value 0 the absence or less intensity is located and in 10 the greater intensity of pain. | immediate post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | Bleeding estimated in consensus between anesthesiologist and surgeon, based on the gauze used during surgery | immediate post surgery | 
| Anesthesia application time | The interval of time in minutes that is required to apply the anesthetic method chosen in the area to be used | at the beginning of the application of anesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tumescent anesthesia, tenosynovitis, Visual Analog Scale, Tourniquets, Epinephrine