Anesthesia Tumescent for Surgical Management of Tenosynovitis.

Tenosynovitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03914235
• Other study ID #: R-2018-1301-021
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: April 8, 2019

Study information

• Verified date: April 2019
• Source: Instituto Mexicano del Seguro Social
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 8, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tenosynovitis

Intervention

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.

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).

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.

Locations

Country	Name	City	State
Mexico	Western Medical Center, Mexican Institute of Social Security	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	immediate post surgery
Secondary	Bleeding	Bleeding estimated in consensus between anesthesiologist and surgeon, based on the gauze used during surgery	immediate post surgery
Secondary	Anesthesia application time	The interval of time in minutes that is required to apply the anesthetic method chosen in the area to be used	at the beginning of the application of anesthesia