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Anesthesia Tumescent for Surgical Management of Tenosynovitis.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03914235
Enrollment
60
Registered
2019-04-16
Start date
2018-08-01
Completion date
2019-04-08
Last updated
2019-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tenosynovitis

Keywords

Tumescent anesthesia, tenosynovitis, Visual Analog Scale, Tourniquets, Epinephrine

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.

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).

Interventions

COMBINATION_PRODUCTTumescent 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.

DRUGLidocaine

Apply 3 to 20 ml at the incision site, depending on the pathology to be repaired(carpal tunnel syndrome, trigger finger or Quervain syndrome).

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

PROCEDUREOpen release of the tendon

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

Sponsors

Instituto Mexicano del Seguro Social
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Procedure pain: Visual Analog Scaleimmediate post surgeryEvaluated 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

MeasureTime frameDescription
Bleedingimmediate post surgeryBleeding estimated in consensus between anesthesiologist and surgeon, based on the gauze used during surgery
Anesthesia application timeat the beginning of the application of anesthesiaThe interval of time in minutes that is required to apply the anesthetic method chosen in the area to be used

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026