Anesthesia Tumescent for Surgical Management of Tenosynovitis.

NCT ID: NCT03914235

Last Updated: 2019-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2019-04-08

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).

Conditions

Tenosynovitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tumescent Anesthesia

Intervention Type: 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.

Open release of the tendon

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: 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).

Pneumatic tourniquet

Intervention Type: DEVICE

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

Open release of the tendon

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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).

Intervention Type: DRUG

Pneumatic tourniquet

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

Intervention Type: DEVICE

Open release of the tendon

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

Intervention Type: PROCEDURE

Other Intervention Names

Lidocaine 1%

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role: lead

Responsible Party

CLOTILDE FUENTES OROZCO

Investigador de tiempo completo

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clotilde Fuentes Orozco, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Mexicano del Seguro Social

Locations

Western Medical Center, Mexican Institute of Social Security

Guadalajara, Jalisco, Mexico

Countries

Mexico

Other Identifiers

R-2018-1301-021

Identifier Type: -

Identifier Source: org_study_id