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Anesthesia Tumescent for Surgical Management of Tenosynovitis.

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ClinicalTrials.gov Identifier: NCT03914235
Recruitment Status : Completed
First Posted : April 15, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
CLOTILDE FUENTES OROZCO, Instituto Mexicano del Seguro Social

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tenosynovitis Combination Product: Tumescent Anesthesia Drug: Lidocaine Device: Pneumatic tourniquet Procedure: Open release of the tendon Not Applicable

Detailed Description:

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Tumescent Local Anesthesia in the Surgical Management of Tenosynovitis.
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : April 8, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Combination Product: Tumescent Anesthesia
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.

Procedure: Open release of the tendon
Standard surgical procedure for carpal tunnel syndrome, trigger finger and Quervain syndrome.

Active Comparator: 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.

Drug: Lidocaine
Apply 3 to 20 ml at the incision site, depending on the pathology to be repaired(carpal tunnel syndrome, trigger finger or Quervain syndrome).
Other Name: Lidocaine 1%

Device: Pneumatic tourniquet
Level of the forearm at 250 mmHg, after exsanguination with Esmarch bandage.

Procedure: Open release of the tendon
Standard surgical procedure for carpal tunnel syndrome, trigger finger and Quervain syndrome.




Primary Outcome Measures :
  1. Procedure pain: Visual Analog Scale [ Time Frame: 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.


Secondary Outcome Measures :
  1. Bleeding [ Time Frame: immediate post surgery ]
    Bleeding estimated in consensus between anesthesiologist and surgeon, based on the gauze used during surgery

  2. Anesthesia application time [ Time Frame: at the beginning of the application of anesthesia ]
    The interval of time in minutes that is required to apply the anesthetic method chosen in the area to be used



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914235


Locations
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Mexico
Western Medical Center, Mexican Institute of Social Security
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
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Principal Investigator: Clotilde Fuentes Orozco, PhD Instituto Mexicano del Seguro Social

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Responsible Party: CLOTILDE FUENTES OROZCO, Investigador de tiempo completo, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT03914235     History of Changes
Other Study ID Numbers: R-2018-1301-021
First Posted: April 15, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by CLOTILDE FUENTES OROZCO, Instituto Mexicano del Seguro Social:
Tumescent anesthesia
tenosynovitis
Visual Analog Scale
Tourniquets
Epinephrine
Additional relevant MeSH terms:
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Tenosynovitis
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Lidocaine
Epinephrine
Racepinephrine
Anesthetics
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics