An interventional study of Tumescent Anesthesia and Lidocaine in Tenosynovitis, sponsored by Instituto Mexicano del Seguro Social. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-29.
Sponsored by Instituto Mexicano del Seguro Social · Not applicable, Interventional, and Treatment
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.
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).
17 studies on the registry are indexed under Tenosynovitis; 4 are open to participants now.
This study's enrollment of 60 is above the median of 52 across 13 interventional studies indexed under Tenosynovitis.
Browse Tenosynovitis studies →Instituto Mexicano del Seguro Social is the lead sponsor of 126 studies on the registry; 21 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Procedure: Open release of the tendon
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 · Device: Pneumatic tourniquet · Procedure: Open release of the tendon
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.
Apply 3 to 20 ml at the incision site, depending on the pathology to be repaired(carpal tunnel syndrome, trigger finger or Quervain syndrome).
Also known as: Lidocaine 1%
Level of the forearm at 250 mmHg, after exsanguination with Esmarch bandage.
Standard surgical procedure for carpal tunnel syndrome, trigger finger and Quervain syndrome.
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.
Time frame: immediate post surgery
Bleeding
Bleeding estimated in consensus between anesthesiologist and surgeon, based on the gauze used during surgery
Time frame: 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
Time frame: at the beginning of the application of anesthesia
Plan to share: No
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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