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Completed

NCT Number: NCT03914235

Anesthesia Tumescent for Surgical Management of Tenosynovitis.

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.

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Key information

Conditions

Tenosynovitis Muscular Diseases Musculoskeletal Diseases Tendinopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western Medical Center, Mexican Institute of Social Security

Guadalajara, Jalisco, 44340, Mexico

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tumescent Anesthesia

Combination Product

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.

Lidocaine

Drug

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 names: Lidocaine 1%

Pneumatic Tourniquet

Device

Level of the forearm at 250 mmHg, after exsanguination with Esmarch bandage.

Open release of the tendon

Procedure

Standard surgical procedure for carpal tunnel syndrome, trigger finger and Quervain syndrome.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 16, 2019
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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