NCT03914235

Anesthesia Tumescent for Surgical Management of Tenosynovitis.

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Instituto Mexicano del Seguro Social · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Tenosynovitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-03-31
• Completion: 2019-04-08
• First posted: 2019-04-16
• Last updated: 2019-04-29

Locations

1 site across 1 country: Mexico