Anesthesia Tumescent for Surgical Management of Tenosynovitis.

NCT03914235 | Completed

• 1 other identifier: R-2018-1301-021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Tenosynovitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Bleeding

  immediate post surgery

• Anesthesia application time

  at the beginning of the application of anesthesia

Study Arms (2)

Tumescent anesthesia

EXPERIMENTAL

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.

Combination Product: Tumescent Anesthesia; Procedure: Open release of the tendon

Local anesthesia with tourniquet.

ACTIVE COMPARATOR

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.

Drug: Lidocaine; Device: Pneumatic tourniquet; Procedure: Open release of the tendon

Interventions

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.

Tumescent anesthesia

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).

Also known as: Lidocaine 1%

Local anesthesia with tourniquet.

Pneumatic tourniquet DEVICE

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

Local anesthesia with tourniquet.

Open release of the tendon PROCEDURE

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

Local anesthesia with tourniquet.; Tumescent anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Western Medical Center, Mexican Institute of Social Security

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Tenosynovitis

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Clotilde Fuentes Orozco, PhD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigador de tiempo completo

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 16, 2019
• Study Start: August 1, 2018
• Primary Completion: March 31, 2019
• Study Completion: April 8, 2019
• Last Updated: April 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)