Efficacy of Tumescent Local Anesthesia in the Surgical Management of Tenosynovitis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Procedure pain: Visual Analog Scale
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Tumescent anesthesia
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.
干预措施: Tumescent Anesthesia (Combination Product)
Tumescent anesthesia
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.
干预措施: Open release of the tendon (Procedure)
Local anesthesia with tourniquet.
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.
干预措施: Lidocaine (Drug)
Local anesthesia with tourniquet.
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.
干预措施: Pneumatic tourniquet (Device)
Local anesthesia with tourniquet.
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.
干预措施: Open release of the tendon (Procedure)
结局指标
主要结局
Procedure pain: Visual Analog Scale
时间窗: immediate post surgery
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.
次要结局
- Anesthesia application time(at the beginning of the application of anesthesia)
- Bleeding(immediate post surgery)
研究者
CLOTILDE FUENTES OROZCO
Investigador de tiempo completo
Instituto Mexicano del Seguro Social